Trial Outcomes & Findings for Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations (NCT NCT02124772)

NCT ID: NCT02124772

Last Updated: 2021-07-14

Results Overview

Incidence of treatment emergent adverse events is defined as number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes from baseline in vital signs and laboratory results qualifying and reported as AEs. The number of participants in each category is reported in the table.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 139 participants
• Primary outcome timeframe: From the day of the first dose of trametinib up to 30 days after the last dose, up to maximum duration of 64 months
• Results posted on: 2021-07-14

Participant Flow

Participants took part in 16 investigative sites in 5 countries.

The participants were screened within 14 days prior to enrollment. After screening, the treatment period started on Cycle 1 Day 1.

Participant milestones

Measure	Part A - TMT 0.0125 mg/kg/Day Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Overall Study STARTED	3	19	12	16	11	10	10	10	3	9	6	20	10
Overall Study COMPLETED	0	5	6	3	2	2	2	1	2	2	4	14	8
Overall Study NOT COMPLETED	3	14	6	13	9	8	8	9	1	7	2	6	2

Reasons for withdrawal

Measure	Part A - TMT 0.0125 mg/kg/Day Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Overall Study Lack of Efficacy	2	0	0	1	2	3	0	2	0	1	0	0	1
Overall Study Adverse Event	1	4	1	5	2	1	1	5	0	3	1	3	1
Overall Study Withdrawal consent	0	1	1	1	0	1	1	0	0	1	0	1	0
Overall Study Investigator discretion	0	2	2	1	1	0	1	0	0	1	0	1	0
Overall Study Progressive disease	0	0	0	0	0	0	1	1	0	0	0	0	0
Overall Study Other	0	7	2	5	4	3	4	1	1	1	1	1	0

Baseline Characteristics

Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations

Baseline characteristics by cohort

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=19 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=12 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=16 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=11 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=10 Participants Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D n=3 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D n=9 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D n=6 Participants Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG n=20 Participants Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH n=10 Participants Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Total n=139 Participants Total of all reporting groups
Age, Customized < 2 years	0 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	10 Participants n=36 Participants
Age, Customized 2 - <6 years	1 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	5 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	5 Participants n=42 Participants	2 Participants n=42 Participants	6 Participants n=36 Participants	48 Participants n=36 Participants
Age, Customized 6 - <12 years	1 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	9 Participants n=42 Participants	3 Participants n=36 Participants	43 Participants n=36 Participants
Age, Customized ≥ 12 years	1 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	4 Participants n=24 Participants	2 Participants n=42 Participants	5 Participants n=42 Participants	0 Participants n=42 Participants	9 Participants n=42 Participants	1 Participants n=36 Participants	38 Participants n=36 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	5 Participants n=8 Participants	5 Participants n=24 Participants	0 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	10 Participants n=42 Participants	2 Participants n=36 Participants	64 Participants n=36 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	12 Participants n=7 Participants	6 Participants n=5 Participants	9 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=8 Participants	5 Participants n=8 Participants	5 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	10 Participants n=42 Participants	8 Participants n=36 Participants	75 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	8 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	9 Participants n=36 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	16 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants	9 Participants n=21 Participants	6 Participants n=8 Participants	7 Participants n=8 Participants	5 Participants n=24 Participants	2 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	16 Participants n=42 Participants	3 Participants n=36 Participants	98 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=36 Participants	21 Participants n=36 Participants

PRIMARY outcome

Timeframe: From the day of the first dose of trametinib up to 30 days after the last dose, up to maximum duration of 64 months

Population: All subjects who received at least one dose of trametinib in Part A and B

Incidence of treatment emergent adverse events is defined as number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes from baseline in vital signs and laboratory results qualifying and reported as AEs. The number of participants in each category is reported in the table.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=19 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=12 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=16 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=11 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=10 Participants Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib Monotherapy AEs	3 Participants	19 Participants	12 Participants	16 Participants	11 Participants	10 Participants	10 Participants	10 Participants	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib Monotherapy Treatment-related AEs	3 Participants	19 Participants	12 Participants	16 Participants	10 Participants	10 Participants	10 Participants	10 Participants	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib Monotherapy SAEs	1 Participants	8 Participants	3 Participants	11 Participants	6 Participants	6 Participants	6 Participants	5 Participants	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib Monotherapy Treatment-related SAEs	0 Participants	5 Participants	1 Participants	6 Participants	1 Participants	2 Participants	2 Participants	3 Participants	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib Monotherapy Fatal SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib Monotherapy AEs leading to discontinuation	1 Participants	4 Participants	1 Participants	6 Participants	4 Participants	1 Participants	1 Participants	5 Participants	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib Monotherapy AEs requiring dose interruptions	0 Participants	12 Participants	6 Participants	14 Participants	3 Participants	8 Participants	5 Participants	8 Participants	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib Monotherapy AEs requiring dose reductions	0 Participants	9 Participants	5 Participants	9 Participants	2 Participants	4 Participants	3 Participants	7 Participants	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib Monotherapy AEs requiring dose reductions or interruptions	0 Participants	13 Participants	7 Participants	14 Participants	3 Participants	8 Participants	6 Participants	9 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of trametinib in Part A and B and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on trametinib plasma concentrations by using non-compartmental methods. The average steady state plasma concentration (Cavg) of trametinib was calculated as the ratio of area under the curve (AUC)/tau, where tau = 24 h for trametinib.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=18 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=9 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=15 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=9 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=9 Participants Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day n=38 Participants Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Average Steady State Plasma Concentration (Cavg) of Trametinib When Administered Alone (Monotherapy)	5.76 ng/mL Geometric Coefficient of Variation 24.8	13.9 ng/mL Geometric Coefficient of Variation 27.1	15.2 ng/mL Geometric Coefficient of Variation 16.9	21.3 ng/mL Geometric Coefficient of Variation 20.7	15.1 ng/mL Geometric Coefficient of Variation 36.0	13.2 ng/mL Geometric Coefficient of Variation 40.4	13.5 ng/mL Geometric Coefficient of Variation 25.1	15.8 ng/mL Geometric Coefficient of Variation 42.8	14.3 ng/mL Geometric Coefficient of Variation 35.8	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: pre dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of trametinib in Part A, B, C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on trametinib plasma concentrations by using non-compartmental methods. Ctrough is defined as the observed plasma concentration just prior to the beginning of, or at the end, of a dosing interval.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=19 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=9 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=15 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=9 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=9 Participants Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day n=38 Participants Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D n=1 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D n=1 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D n=6 Participants Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG n=20 Participants Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH n=6 Participants Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D n=5 Participants Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D n=21 Participants Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Trough Concentration (Ctrough) of Trametinib When Administered Alone and in Combination With Dabrafenib	4.37 ng/mL Geometric Coefficient of Variation 30.6	11.1 ng/mL Geometric Coefficient of Variation 44.0	10.2 ng/mL Geometric Coefficient of Variation 19.4	15.6 ng/mL Geometric Coefficient of Variation 30.1	10.7 ng/mL Geometric Coefficient of Variation 43.3	9.45 ng/mL Geometric Coefficient of Variation 53.6	9.25 ng/mL Geometric Coefficient of Variation 29.0	11.3 ng/mL Geometric Coefficient of Variation 50.3	10.1 ng/mL Geometric Coefficient of Variation 43.6	8.31 ng/mL	10.2 ng/mL	3.86 ng/mL Geometric Coefficient of Variation 34.9	8.60 ng/mL Geometric Coefficient of Variation 42.2	3.74 ng/mL Geometric Coefficient of Variation 66.3	3.05 ng/mL Geometric Coefficient of Variation 50.7	8.68 ng/mL Geometric Coefficient of Variation 38.6

SECONDARY outcome

Timeframe: pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15 (part A and B) and pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15 (part C and D). The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of trametinib in Part A, B, C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on trametinib plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=18 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=9 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=16 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=9 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=9 Participants Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day n=38 Participants Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D n=1 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D n=1 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D n=6 Participants Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG n=20 Participants Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH n=6 Participants Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D n=5 Participants Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D n=21 Participants Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Maximum Observed Plasma Concentration (Cmax) of Trametinib When Administered Alone and in Combination With Dabrafenib	9.61 ng/mL Geometric Coefficient of Variation 32.9	21.1 ng/mL Geometric Coefficient of Variation 33.3	26.1 ng/mL Geometric Coefficient of Variation 16.8	32.6 ng/mL Geometric Coefficient of Variation 28.9	26.6 ng/mL Geometric Coefficient of Variation 39.6	22.1 ng/mL Geometric Coefficient of Variation 41.9	21.6 ng/mL Geometric Coefficient of Variation 26.1	27.5 ng/mL Geometric Coefficient of Variation 31.6	24.2 ng/mL Geometric Coefficient of Variation 35.6	26.0 ng/mL	24.5 ng/mL	23.7 ng/mL Geometric Coefficient of Variation 36.3	22.9 ng/mL Geometric Coefficient of Variation 29.2	15.6 ng/mL Geometric Coefficient of Variation 52.5	25.9 ng/mL Geometric Coefficient of Variation 35.8	20.0 ng/mL Geometric Coefficient of Variation 38.1

SECONDARY outcome

Timeframe: pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15 (part A and B) and pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15 (part C and D). The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of trametinib in Part A, B, C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on trametinib plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=19 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=9 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=16 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=9 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=9 Participants Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day n=38 Participants Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D n=1 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D n=1 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D n=6 Participants Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG n=20 Participants Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH n=6 Participants Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D n=5 Participants Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D n=21 Participants Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Time to Reach Maximum Plasma Concentration (Tmax) of Trametinib When Administered Alone and in Combination With Dabrafenib	1.00 hours Interval 1.0 to 2.0	2.00 hours Interval 1.0 to 4.0	1.00 hours Interval 1.0 to 2.0	2.00 hours Interval 1.0 to 24.0	1.00 hours Interval 1.0 to 4.0	1.50 hours Interval 1.0 to 2.0	1.00 hours Interval 1.0 to 2.0	1.00 hours Interval 1.0 to 2.0	1.00 hours Interval 1.0 to 4.0	1.00 hours Interval 1.0 to 1.0	1.00 hours Interval 1.0 to 1.0	1.50 hours Interval 1.0 to 2.0	2.00 hours Interval 1.0 to 3.0	1.00 hours Interval 1.0 to 4.0	1.00 hours Interval 1.0 to 1.0	2.00 hours Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15 (part A and B) and pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15 (part C and D). The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of trametinib in Part A, B, C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on trametinib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for area under the curve calculation.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=19 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=9 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=16 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=9 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=9 Participants Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day n=38 Participants Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D n=1 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D n=1 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D n=6 Participants Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG n=20 Participants Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH n=6 Participants Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D n=5 Participants Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D n=21 Participants Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Trametinib When Administered Alone and in Combination With Dabrafenib	138 hours*ng/mL Geometric Coefficient of Variation 24.8	341 hours*ng/mL Geometric Coefficient of Variation 28.3	364 hours*ng/mL Geometric Coefficient of Variation 16.9	413 hours*ng/mL Geometric Coefficient of Variation 76.2	362 hours*ng/mL Geometric Coefficient of Variation 36.0	316 hours*ng/mL Geometric Coefficient of Variation 40.4	304 hours*ng/mL Geometric Coefficient of Variation 36.9	379 hours*ng/mL Geometric Coefficient of Variation 42.8	337 hours*ng/mL Geometric Coefficient of Variation 38.6	290 hours*ng/mL	331 hours*ng/mL	122 hours*ng/mL Geometric Coefficient of Variation 29.0	270 hours*ng/mL Geometric Coefficient of Variation 35.8	118 hours*ng/mL Geometric Coefficient of Variation 53.4	126 hours*ng/mL Geometric Coefficient of Variation 30.7	255 hours*ng/mL Geometric Coefficient of Variation 49.2

SECONDARY outcome

Timeframe: pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15 (part A and B) and pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15 (part C and D). The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of trametinib in Part A, B, C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on trametinib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for area under the curve calculation. The duration of the dosing interval (tau) was 24 hours for trametinib.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=18 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=9 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=15 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=9 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=9 Participants Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day n=38 Participants Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D n=1 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D n=1 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D n=6 Participants Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG n=20 Participants Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH n=6 Participants Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D n=5 Participants Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D n=21 Participants Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau at Steady-state (AUCtau) of Trametinib When Administered Alone and in Combination With Dabrafenib	138 hours*ng/mL Geometric Coefficient of Variation 24.8	334 hours*ng/mL Geometric Coefficient of Variation 27.1	364 hours*ng/mL Geometric Coefficient of Variation 16.9	511 hours*ng/mL Geometric Coefficient of Variation 20.7	362 hours*ng/mL Geometric Coefficient of Variation 36.0	316 hours*ng/mL Geometric Coefficient of Variation 40.4	323 hours*ng/mL Geometric Coefficient of Variation 25.1	379 hours*ng/mL Geometric Coefficient of Variation 42.8	343 hours*ng/mL Geometric Coefficient of Variation 35.8	290 hours*ng/mL	331 hours*ng/mL	236 hours*ng/mL Geometric Coefficient of Variation 28.4	308 hours*ng/mL Geometric Coefficient of Variation 20.0	186 hours*ng/mL Geometric Coefficient of Variation 23.7	228 hours*ng/mL Geometric Coefficient of Variation 33.1	286 hours*ng/mL Geometric Coefficient of Variation 28.4

SECONDARY outcome

Timeframe: pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15 (part A and B) and pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15 (part C and D). The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of trametinib in Part A, B, C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on trametinib plasma concentrations by using non-compartmental methods. Apparent plasma clearance (CL/F) values were calculated as Dose/AUCtau.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=18 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=9 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=15 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=9 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=9 Participants Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day n=38 Participants Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D n=1 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D n=1 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D n=6 Participants Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG n=20 Participants Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH n=6 Participants Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D n=5 Participants Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D n=21 Participants Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Apparent Plasma Clearance (CL/F) of Trametinib When Administered Alone and in Combination With Dabrafenib	2750 mL/hour Geometric Coefficient of Variation 69.4	1530 mL/hour Geometric Coefficient of Variation 64.5	1240 mL/hour Geometric Coefficient of Variation 25.5	2040 mL/hour Geometric Coefficient of Variation 71.5	1710 mL/hour Geometric Coefficient of Variation 55.6	1910 mL/hour Geometric Coefficient of Variation 47.8	1590 mL/hour Geometric Coefficient of Variation 65.3	1820 mL/hour Geometric Coefficient of Variation 42.6	1750 mL/hour Geometric Coefficient of Variation 51.5	2590 mL/hour	3770 mL/hour	2010 mL/hour Geometric Coefficient of Variation 38.5	3540 mL/hour Geometric Coefficient of Variation 54.0	3060 mL/hour Geometric Coefficient of Variation 44.9	2180 mL/hour Geometric Coefficient of Variation 23.9	3810 mL/hour Geometric Coefficient of Variation 49.6

SECONDARY outcome

Timeframe: pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of trametinib in Part C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on trametinib plasma concentrations by using non-compartmental methods. The average steady state plasma concentration (Cavg) of trametinib was calculated as the ratio of area under the curve (AUC)/tau, where tau = 24 h for trametinib.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=1 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=1 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=6 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=20 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=6 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=5 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=21 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Average Steady State Plasma Concentration (Cavg) of Trametinib When Administered in Combination With Dabrafenib	12.1 ng/mL	13.8 ng/mL	9.83 ng/mL Geometric Coefficient of Variation 28.4	12.8 ng/mL Geometric Coefficient of Variation 20.0	7.76 ng/mL Geometric Coefficient of Variation 23.7	9.50 ng/mL Geometric Coefficient of Variation 33.1	11.9 ng/mL Geometric Coefficient of Variation 28.4	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the day of the first dose of the combination up to 30 days after the last dose, up to maximum duration of 53 months

Population: All subjects who received at least one dose of any component of the combination in Part C and Part D

Incidence of treatment emergent adverse events is defined as number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes from baseline in vital signs and laboratory results qualifying and reported as AEs. The number of participants in each category is reported in the table.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=9 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=6 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=20 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib in Combination With Dabrafenib AEs	3 Participants	9 Participants	6 Participants	20 Participants	10 Participants	—	—	—	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib in Combination With Dabrafenib Treatment-related AEs	3 Participants	9 Participants	6 Participants	20 Participants	10 Participants	—	—	—	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib in Combination With Dabrafenib SAEs	1 Participants	5 Participants	2 Participants	8 Participants	6 Participants	—	—	—	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib in Combination With Dabrafenib Treatment-related SAEs	0 Participants	2 Participants	1 Participants	5 Participants	3 Participants	—	—	—	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib in Combination With Dabrafenib Fatal SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib in Combination With Dabrafenib AEs leading to discontinuation	0 Participants	3 Participants	1 Participants	5 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib in Combination With Dabrafenib AEs requiring dose interruptions	1 Participants	6 Participants	4 Participants	16 Participants	8 Participants	—	—	—	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib in Combination With Dabrafenib AEs requiring dose reductions	1 Participants	3 Participants	1 Participants	6 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib in Combination With Dabrafenib AEs requiring dose reductions or interruptions	1 Participants	7 Participants	4 Participants	16 Participants	8 Participants	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the day of the first dose of any study drug up to the last dose, up to maximum duration of 63 months

Population: All subjects who received at least one dose of trametinib in Part A and Part B or at least one dose of any component of the combination in Part C and Part D

Response evaluations were assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for subjects with solid tumors except neuroblastomas, primary central nervous system tumors (gliomas) or plexiform neurofibromas (PNs).

Response evaluations for subjects with neuroblastomas could have included: measureable disease (by CT/MRI alone) assessed according to RECIST v1.1, evaluable disease assessed for meta-iodobenzylguanidine (MIBG) response, and biochemical (urine HVA/VMA) with bone marrow involvement assessed by Hematoxylin and Eosin staining of bilateral bone marrow biopsies and aspirates.

Response evaluations for glioma subjects was assessed using Response Assessment in Neuro Oncology (RANO) criteria with solid tumors through MRI scans.

Response evaluations of PNs were assessed using volumetric determination and Dombi criteria through MRI scans.

The number of participants in each response category is reported in the table.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=19 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=12 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=16 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=11 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=10 Participants Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day n=3 Participants Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D n=9 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D n=6 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D n=20 Participants Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG n=10 Participants Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Best Overall Response (BOR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment Complete response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	3 Participants	—	—	—
Best Overall Response (BOR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment Partial response (PR)	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	3 Participants	0 Participants	5 Participants	2 Participants	3 Participants	2 Participants	9 Participants	3 Participants	—	—	—
Best Overall Response (BOR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment Stable disease (SD)	1 Participants	2 Participants	3 Participants	4 Participants	1 Participants	7 Participants	8 Participants	4 Participants	1 Participants	5 Participants	1 Participants	8 Participants	3 Participants	—	—	—
Best Overall Response (BOR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment Progressive disease (PD)	0 Participants	0 Participants	2 Participants	0 Participants	5 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Best Overall Response (BOR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment Non-CR/Non-PD	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Best Overall Response (BOR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment Unknown	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Best Overall Response (BOR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment Missing	2 Participants	16 Participants	6 Participants	10 Participants	3 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: From the day of the first dose of any study drug up to the last dose, up to maximum duration of 63 months

Population: All subjects who received at least one dose of trametinib in Part A and Part B or at least one dose of any component of the combination in Part C and Part D

Objective response rate (ORR) was defined as the percentage of subjects with best overall response rate (BOR) with confirmation of complete response (CR) or partial response (PR) according to criteria for a specific disease type, among subjects with disease assessment at baseline. BOR for each subject was determined from the sequence of overall responses according to the rules for RECIST v1.1, RANO and Dombi criteria. ORR was calculated based on the investigator assessment of tumor response data and was based on confirmed responses.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=19 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=12 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=16 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=11 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=10 Participants Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day n=3 Participants Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D n=9 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D n=6 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D n=20 Participants Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG n=10 Participants Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Objective Response Rate (ORR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment	0 percentage of participants Interval 0.0 to 70.8	5.3 percentage of participants Interval 0.1 to 26.0	8.3 percentage of participants Interval 0.2 to 38.5	0 percentage of participants Interval 0.0 to 20.6	9.1 percentage of participants Interval 0.2 to 41.3	30.0 percentage of participants Interval 6.7 to 65.2	0 percentage of participants Interval 0.0 to 30.8	50.0 percentage of participants Interval 18.7 to 81.3	66.7 percentage of participants Interval 9.4 to 99.2	33.3 percentage of participants Interval 7.5 to 70.1	66.7 percentage of participants Interval 22.3 to 95.7	55.0 percentage of participants Interval 31.5 to 76.9	60.0 percentage of participants Interval 26.2 to 87.8	—	—	—

SECONDARY outcome

Timeframe: From the day of the first dose of any study drug up to the last dose, up to maximum duration of 63 months

Population: All subjects who received at least one dose of trametinib in Part A and Part B or at least one dose of any component of the combination in Part C and Part D

Clinical Benefit Rate (CBR) was defined as the percentage of subjects with best overall response rate (BOR) with confirmation of complete response (CR), partial response (PR) or stable disease (SD) according to criteria for a specific disease type, among subjects with disease assessment at baseline. BOR for each subject was determined from the sequence of overall responses according to the rules for RECIST v1.1, RANO and Dombi criteria. ORR was calculated based on the investigator assessment of tumor response data and was based on confirmed responses.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=19 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=12 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=16 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=11 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=10 Participants Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day n=3 Participants Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D n=9 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D n=6 Participants Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D n=20 Participants Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG n=10 Participants Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Clinical Benefit Rate (CBR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment	33.3 percentage of participants Interval 0.8 to 90.6	15.8 percentage of participants Interval 3.4 to 39.6	33.3 percentage of participants Interval 9.9 to 65.1	25.0 percentage of participants Interval 7.3 to 52.4	18.2 percentage of participants Interval 2.3 to 51.8	100 percentage of participants Interval 69.2 to 100.0	80.0 percentage of participants Interval 44.4 to 97.5	90.0 percentage of participants Interval 55.5 to 99.7	100 percentage of participants Interval 29.2 to 100.0	88.9 percentage of participants Interval 51.8 to 99.7	83.3 percentage of participants Interval 35.9 to 99.6	95.0 percentage of participants Interval 75.1 to 99.9	90.0 percentage of participants Interval 55.5 to 99.7	—	—	—

SECONDARY outcome

Timeframe: pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15 (part A and B) and pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15 (part C and D). The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of trametinib in Part A, B, C and D and provided an evaluable PK profile. All trametinib and dabrafenib concentration-time data were combined and included in a population PK analysis that examined the influence of demographics on the PK of study treatment.

The population pharmacokinetic (PopPK) model of trametinib can be described using a two-compartment model with dual sequential 1st order absorption (Ka1, Ka2) and 1st order elimination. Apparent clearance (CL/F) of trametinib estimated with the PopPK model is summarized in this record.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=133 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Apparent Clearance (CL/F) of Trametinib Estimated With a PopPK Model	5.07 liters/hour	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15 (part A and B) and pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15 (part C and D). The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of trametinib in Part A, B, C and D and provided an evaluable PK profile. All trametinib and dabrafenib concentration-time data were combined and included in a population PK analysis that examined the influence of demographics on the PK of study treatment.

The population pharmacokinetic (PopPK) model of trametinib can be described using a two-compartment model with dual sequential 1st order absorption (Ka1, Ka2) and 1st order elimination. Apparent central volume (Vc/F) of trametinib estimated with the PopPK model is summarized in this record.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=133 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Apparent Central Volume (Vc/F) of Trametinib Estimated With a PopPK Model	184 liters	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15 (part A and B) and pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15 (part C and D). The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of trametinib in Part A, B, C and D and provided an evaluable PK profile. All trametinib and dabrafenib concentration-time data were combined and included in a population PK analysis that examined the influence of demographics on the PK of study treatment.

The population pharmacokinetic (PopPK) model of trametinib can be described using a two-compartment model with dual sequential 1st order absorption (Ka1, Ka2) and 1st order elimination. The absorption rate constants (Ka1 and Ka2) estimated with the PopPK model are summarized in this record.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=133 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Absorption Rate Constants (Ka1 and Ka2) of Trametinib Estimated With a PopPK Model Ka1	0.134 1/hours	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Absorption Rate Constants (Ka1 and Ka2) of Trametinib Estimated With a PopPK Model Ka2	1.55 1/hours	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15 (part A and B) and pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15 (part C and D). The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of trametinib in Part A, B, C and D and provided an evaluable PK profile. All trametinib and dabrafenib concentration-time data were combined and included in a population PK analysis that examined the influence of demographics on the PK of study treatment.

The population pharmacokinetic (PopPK) model of trametinib can be described using a two-compartment model with dual sequential 1st order absorption (Ka1, Ka2) and 1st order elimination. Sex and weight are significant covariates on apparent clearance (CL/F), and weight is also a significant covariate on apparent intercompartmental clearance (Q/F). Use of dabrafenib, yes or no, is a covariate on the relative bioavailability of trametinib, reflecting the effect of dabrafenib on the PK of trametinib.

The estimates of these covariates (effect of weight on CL/F, effect of sex on CL/F, effect of weight on Q/F, effect of combination with dabrafenib on relative bioavailability F1) calculated with the PopPK model are summarized in this record.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=133 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Significant Covariates Estimated With a PopPK Model Effect of weight on CL/F	0.788 no units	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Significant Covariates Estimated With a PopPK Model Effect of sex on CL/F	1.24 no units	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Significant Covariates Estimated With a PopPK Model Effect of weight on Q/F	0.679 no units	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Significant Covariates Estimated With a PopPK Model Effect of combination with dabrafenib on relative bioavailability F1	0.876 no units	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: pre dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of dabrafenib in Part C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on dabrafenib plasma concentrations by using non-compartmental methods. Ctrough is defined as the observed plasma concentration just prior to the beginning of, or at the end, of a dosing interval.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=7 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=6 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=19 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=8 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=6 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=21 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Trough Concentration (Ctrough) of Dabrafenib When Administered in Combination With Trametinib	88.9 ng/mL Geometric Coefficient of Variation 99.6	28.6 ng/mL Geometric Coefficient of Variation 203.5	8.10 ng/mL Geometric Coefficient of Variation 159.6	38.2 ng/mL Geometric Coefficient of Variation 130.9	11.8 ng/mL Geometric Coefficient of Variation 869.4	5.36 ng/mL Geometric Coefficient of Variation 429.6	42.7 ng/mL Geometric Coefficient of Variation 137.4	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post dabrafenib dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of dabrafenib in Part C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on dabrafenib plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=7 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=6 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=19 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=8 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=6 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=21 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Maximum Observed Plasma Concentration (Cmax) of Dabrafenib When Administered in Combination With Trametinib	630 ng/mL Geometric Coefficient of Variation 235.2	1560 ng/mL Geometric Coefficient of Variation 35.3	1440 ng/mL Geometric Coefficient of Variation 43.3	1360 ng/mL Geometric Coefficient of Variation 55.6	1490 ng/mL Geometric Coefficient of Variation 88.1	1840 ng/mL Geometric Coefficient of Variation 35.2	1290 ng/mL Geometric Coefficient of Variation 68.7	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post dabrafenib dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of dabrafenib in Part C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on dabrafenib plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=7 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=6 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=19 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=8 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=6 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=21 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Time to Reach Maximum Plasma Concentration (Tmax) of Dabrafenib When Administered in Combination With Trametinib	2.00 hours Interval 2.0 to 4.0	1.00 hours Interval 1.0 to 2.0	2.00 hours Interval 1.0 to 2.0	2.00 hours Interval 1.0 to 3.0	1.00 hours Interval 1.0 to 3.0	1.00 hours Interval 1.0 to 3.0	2.00 hours Interval 1.0 to 3.0	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post dabrafenib dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of dabrafenib in Part C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on dabrafenib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for area under the curve calculation.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=7 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=6 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=19 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=8 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=6 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=21 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Dabrafenib When Administered in Combination With Trametinib	2560 hours*ng/mL Geometric Coefficient of Variation 157.1	4160 hours*ng/mL Geometric Coefficient of Variation 24.6	3910 hours*ng/mL Geometric Coefficient of Variation 48.8	4030 hours*ng/mL Geometric Coefficient of Variation 46.4	3800 hours*ng/mL Geometric Coefficient of Variation 35.4	3990 hours*ng/mL Geometric Coefficient of Variation 28.3	3950 hours*ng/mL Geometric Coefficient of Variation 46.9	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post dabrafenib dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of dabrafenib in Part C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on dabrafenib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for area under the curve calculation. The duration of the dosing interval (tau) was 12 hours for dabrafenib.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=7 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=6 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=19 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=8 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=6 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=21 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau at Steady-state (AUCtau) of Dabrafenib When Administered in Combination With Trametinib	2870 hours*ng/mL Geometric Coefficient of Variation 116.6	4160 hours*ng/mL Geometric Coefficient of Variation 24.6	4040 hours*ng/mL Geometric Coefficient of Variation 47.9	4070 hours*ng/mL Geometric Coefficient of Variation 46.7	3910 hours*ng/mL Geometric Coefficient of Variation 37.4	4150 hours*ng/mL Geometric Coefficient of Variation 30.2	3990 hours*ng/mL Geometric Coefficient of Variation 47.3	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post dabrafenib dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of dabrafenib in Part C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on dabrafenib plasma concentrations by using non-compartmental methods. Apparent plasma clearance (CL/F) values were calculated as Dose/AUCtau.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=7 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=6 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=19 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=8 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=6 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=21 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Apparent Plasma Clearance (CL/F) of Dabrafenib When Administered in Combination With Trametinib	22900 mL/hour Geometric Coefficient of Variation 191.2	20400 mL/hour Geometric Coefficient of Variation 45.4	10100 mL/hour Geometric Coefficient of Variation 67.0	25400 mL/hour Geometric Coefficient of Variation 70.5	12500 mL/hour Geometric Coefficient of Variation 63.0	10200 mL/hour Geometric Coefficient of Variation 41.6	25100 mL/hour Geometric Coefficient of Variation 69.3	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post dabrafenib dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.

Population: All subjects who received at least one dose of dabrafenib in Part C and D and provided an evaluable PK profile with a value for the outcome measure

Pharmacokinetic (PK) parameters were calculated based on dabrafenib plasma concentrations by using non-compartmental methods. The average steady state plasma concentration (Cavg) of dabrafenib was calculated as the ratio of area under the curve (AUC)/tau, where tau = 12 h for dabrafenib.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=7 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=6 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=19 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=8 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=6 Participants Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=21 Participants Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Average Steady State Plasma Concentration (Cavg) of Dabrafenib When Administered in Combination With Trametinib	239 ng/mL Geometric Coefficient of Variation 116.6	347 ng/mL Geometric Coefficient of Variation 24.6	337 ng/mL Geometric Coefficient of Variation 47.9	339 ng/mL Geometric Coefficient of Variation 46.7	326 ng/mL Geometric Coefficient of Variation 37.4	346 ng/mL Geometric Coefficient of Variation 30.2	332 ng/mL Geometric Coefficient of Variation 47.3	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: After the first dose of trametinib oral solution and no later than Day 8 (±3 days)

Population: All subjects who received at least one dose of trametinib oral solution and filled in the palatability questionnaire. All palatability questionnaire results were combined and reported based on drug dose to better determine the acceptability and palatability of the formulation.

For subjects ≥ 12 years of age who received the trametinib oral solution, the subject completed a form to evaluate the various properties of the solution (e.g., bitterness, sweetness, appearance, texture and overall taste). For subjects < 12 years of age who received the solution, their caregiver (e.g. parent or guardian) evaluated the solution with the child based on verbal and non-verbal feedback. The questionnaire was completed after the first dose of study drug and no later than Day 8 (±3 days). Subjects completed a form for each drug separately if enrolled in Parts C and D.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day n=2 Participants Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=29 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=21 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=4 Participants Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to mix? · Yes	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to mix? · No	2 Participants	26 Participants	19 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to mix? · missing	0 Participants	2 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to measure? · Yes	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to measure? · No	2 Participants	29 Participants	18 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to measure? · missing	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to administer? · Yes	0 Participants	5 Participants	5 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to administer? · No	2 Participants	24 Participants	15 Participants	3 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to administer? · missing	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject like the taste of the medicine? · Yes	2 Participants	8 Participants	6 Participants	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject like the taste of the medicine? · No	0 Participants	16 Participants	13 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject like the taste of the medicine? · missing	0 Participants	5 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject have difficulty in taking the medicine? · Yes	0 Participants	6 Participants	7 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject have difficulty in taking the medicine? · No	2 Participants	19 Participants	13 Participants	3 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject have difficulty in taking the medicine? · missing	0 Participants	4 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject resist taking the medicine? · Yes	0 Participants	7 Participants	6 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject resist taking the medicine? · No	2 Participants	18 Participants	14 Participants	3 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject resist taking the medicine? · missing	0 Participants	4 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine bitter? · Yes	0 Participants	3 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine bitter? · No	0 Participants	2 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine bitter? · missing	2 Participants	24 Participants	20 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine sweet? · Yes	0 Participants	2 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine sweet? · No	0 Participants	3 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine sweet? · missing	2 Participants	24 Participants	20 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine sour? · Yes	0 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine sour? · No	0 Participants	3 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine sour? · missing	2 Participants	24 Participants	20 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine gritty? · Yes	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine gritty? · No	0 Participants	4 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine gritty? · missing	2 Participants	24 Participants	20 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to swallow? · Yes	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to swallow? · No	0 Participants	5 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to swallow? · missing	2 Participants	23 Participants	20 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: After the first dose of dabrafenib oral suspension and no later than Day 8 (±3 days)

Population: All subjects who received at least one dose of dabrafenib oral suspension and filled in the palatability questionnaire. All palatability questionnaire results were combined and reported based on drug dose to better determine the acceptability and palatability of the formulation. There were no results available for participants who received 50% of the RP2D of dabrafenib monotherapy in combination with trametinib because the participants did not fill in the questionnaire.

For subjects ≥ 12 years of age who received the dabrafenib suspension, the subject completed a form to evaluate the various properties of the suspension (e.g., bitterness, sweetness, appearance, texture and overall taste). For subjects < 12 years of age who received the suspension, their caregiver (e.g. parent or guardian) evaluated the suspension with the child based on verbal and non-verbal feedback. The questionnaire was completed after the first dose of study drug and no later than Day 8 (±3 days). Subjects completed a form for each drug separately if enrolled in Parts C and D.

Outcome measures

Measure	Part A - TMT 0.0125 mg/kg/Day Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=4 Participants Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=6 Participants Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part B - All Tumor Types TMT 0.025 mg/kg/Day Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject have difficulty in taking the medicine? · Yes	—	0 Participants	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject have difficulty in taking the medicine? · No	—	1 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject have difficulty in taking the medicine? · missing	—	3 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject resist taking the medicine? · Yes	—	0 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject resist taking the medicine? · No	—	1 Participants	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject resist taking the medicine? · missing	—	3 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine bitter? · Yes	—	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine bitter? · No	—	2 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine bitter? · missing	—	1 Participants	6 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine sweet? · Yes	—	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine sweet? · No	—	3 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine sweet? · missing	—	1 Participants	6 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine sour? · Yes	—	2 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine sour? · No	—	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine sour? · missing	—	1 Participants	6 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine gritty? · Yes	—	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine gritty? · No	—	2 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine gritty? · missing	—	1 Participants	6 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to swallow? · Yes	—	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to swallow? · No	—	3 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to swallow? · missing	—	1 Participants	6 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to mix? · Yes	—	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to mix? · No	—	4 Participants	5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to mix? · missing	—	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to measure? · Yes	—	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to measure? · No	—	4 Participants	5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to measure? · missing	—	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to administer? · Yes	—	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to administer? · No	—	4 Participants	5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Was the medicine difficult to administer? · missing	—	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject like the taste of the medicine? · Yes	—	0 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject like the taste of the medicine? · No	—	1 Participants	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire Did the subject like the taste of the medicine? · missing	—	3 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Part A - TMT 0.0125 mg/kg/Day

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A - TMT 0.025 mg/kg/Day

Serious events: 8 serious events

Other events: 19 other events

Deaths: 0 deaths

Part A - TMT 0.032 mg/kg/Day

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Part A - TMT 0.04 mg/kg/Day

Serious events: 11 serious events

Other events: 16 other events

Deaths: 0 deaths

Part B - Neuroblastoma

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

Part B - LGG Fusion

Serious events: 6 serious events

Other events: 10 other events

Deaths: 0 deaths

Part B - NF-1 With PN

Serious events: 6 serious events

Other events: 10 other events

Deaths: 0 deaths

Part B - BRAF V600 Mutant Solid Tumor

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Part D - LGG

Serious events: 8 serious events

Other events: 20 other events

Deaths: 0 deaths

Part D - LCH

Serious events: 6 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 participants at risk Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=19 participants at risk Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=12 participants at risk Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=16 participants at risk Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=11 participants at risk Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 participants at risk Participants with recurrent or unresectable low grade glioma (LGG) with BRAF tandem duplication with fusion treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 participants at risk Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=10 participants at risk Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D n=3 participants at risk Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D n=9 participants at risk Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D n=6 participants at risk Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG n=20 participants at risk Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH n=10 participants at risk Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Bradycardia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Tachycardia	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Nausea	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Fatigue	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Hypothermia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Influenza like illness	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Mucosal inflammation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Oedema peripheral	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Pyrexia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 4/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Adenovirus infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Arthritis infective	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Bronchiolitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Cellulitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Device related infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Enterobacter infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Enterococcal bacteraemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Escherichia infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Gastroenteritis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Influenza	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Lymphangitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Medical device site infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Osteomyelitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Paronychia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Parotitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Pelvic abscess	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Pharyngitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Pharyngitis streptococcal	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Pneumonia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Pyelonephritis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Rotavirus infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Sepsis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Skin infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Tonsillitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Varicella	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Vascular device infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Viral infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood bilirubin increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood culture positive	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations C-reactive protein increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Ejection fraction decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Weight decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations White blood cell count decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Kyphosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Spinal instability	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Ataxia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Balance disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Brain oedema	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Depressed level of consciousness	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Dysarthria	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Encephalopathy	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Epilepsy	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Headache	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Hydrocephalus	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Intracranial pressure increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Pyramidal tract syndrome	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Seizure	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.8% 3/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Syncope	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Restlessness	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Haematuria	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Surgical and medical procedures Gastrointestinal tube insertion	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Hypertension	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Hypotension	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.

Other adverse events

Measure	Part A - TMT 0.0125 mg/kg/Day n=3 participants at risk Participants treated with trametinib 0.0125 mg/kg/day	Part A - TMT 0.025 mg/kg/Day n=19 participants at risk Participants treated with trametinib 0.025 mg/kg/day	Part A - TMT 0.032 mg/kg/Day n=12 participants at risk Participants under 6 years of age treated with trametinib 0.032 mg/kg/day	Part A - TMT 0.04 mg/kg/Day n=16 participants at risk Participants treated with trametinib 0.04 mg/kg/day	Part B - Neuroblastoma n=11 participants at risk Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day	Part B - LGG Fusion n=10 participants at risk Participants with recurrent or unresectable low grade glioma (LGG) with BRAF tandem duplication with fusion treated with trametinib 0.025 mg/kg/day	Part B - NF-1 With PN n=10 participants at risk Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day	Part B - BRAF V600 Mutant Solid Tumor n=10 participants at risk Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day	Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D n=3 participants at risk Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D n=9 participants at risk Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D n=6 participants at risk Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)	Part D - LGG n=20 participants at risk Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)	Part D - LCH n=10 participants at risk Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Cardiac disorders Mitral valve disease	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Palpitations	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Gingival oedema	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Gingival swelling	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Haematemesis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Lip blister	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 4/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Stoma site hypergranulation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Stoma site pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Sunburn	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Bradycardia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Cardiac disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	47.4% 9/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 6/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	43.8% 7/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	54.5% 6/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	44.4% 4/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 4/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Bone marrow oedema	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Hypochromasia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Angina pectoris	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Atrioventricular block first degree	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	26.3% 5/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Systolic dysfunction	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Tachycardia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Cardiac disorders Tricuspid valve disease	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Congenital, familial and genetic disorders Phimosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Ear and labyrinth disorders Ear pain	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Ear and labyrinth disorders External ear inflammation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Ear and labyrinth disorders External ear pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Ear and labyrinth disorders Otorrhoea	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Endocrine disorders Adrenocorticotropic hormone deficiency	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Endocrine disorders Growth hormone deficiency	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Endocrine disorders Hypogonadism	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Endocrine disorders Hypothyroidism	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Endocrine disorders Precocious puberty	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Amblyopia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Astigmatism	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Bell's phenomenon	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Blepharitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.8% 3/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Blindness	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Cataract	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Dry eye	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Dyschromatopsia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Erythema of eyelid	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Eye discharge	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.8% 3/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Eye haemorrhage	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Eye pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Eye pruritus	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Eye swelling	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Eyelid margin crusting	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Gaze palsy	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Heterophoria	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Hypermetropia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Iridocyclitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Keratitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Lacrimation increased	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Mydriasis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Ocular hyperaemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Ocular hypertension	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Optic disc disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Optic disc haemorrhage	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Optic nerve disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Periorbital oedema	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Photophobia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Pupillary reflex impaired	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Retinopathy	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Strabismus	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Trichomegaly	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Uveitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Vision blurred	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Visual acuity reduced	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Visual impairment	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Eye disorders Vitreous floaters	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Abdominal mass	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	42.1% 8/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	58.3% 7/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	31.2% 5/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 6/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Abdominal pain upper	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	26.3% 5/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Anal fissure	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Anal incontinence	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Anal inflammation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Anal rash	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Angular cheilitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Chapped lips	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Cheilitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	37.5% 6/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Constipation	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	42.1% 8/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 6/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.8% 3/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	36.4% 4/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	60.0% 6/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 5/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Dental caries	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	89.5% 17/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	83.3% 10/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	56.2% 9/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	54.5% 6/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	60.0% 6/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	60.0% 6/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	66.7% 2/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 3/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	35.0% 7/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Flatulence	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Gingival erythema	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Gingival hypertrophy	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Lip dry	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Lip haemorrhage	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Lip swelling	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Mucous stools	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Nausea	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	31.6% 6/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	27.3% 3/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	44.4% 4/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 8/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Oral disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Oral pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Teething	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Tooth discolouration	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Toothache	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Vomiting	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	68.4% 13/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	75.0% 9/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	37.5% 6/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	27.3% 3/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	60.0% 6/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	44.4% 4/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	66.7% 4/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	45.0% 9/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	70.0% 7/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Asthenia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Catheter site hypersensitivity	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Catheter site pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Catheter site rash	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Chest discomfort	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Chest pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Chills	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Cyst	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Face oedema	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Fatigue	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	52.6% 10/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	75.0% 9/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	60.0% 6/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	66.7% 2/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	44.4% 4/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	45.0% 9/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Feeling cold	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Gait disturbance	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Granuloma	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Hypothermia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Influenza like illness	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Localised oedema	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Malaise	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Mucosal inflammation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Non-cardiac chest pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Oedema peripheral	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Peripheral swelling	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Pyrexia	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	57.9% 11/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	66.7% 8/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	62.5% 10/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	45.5% 5/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	60.0% 6/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	77.8% 7/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	66.7% 4/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	75.0% 15/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	80.0% 8/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Swelling face	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Ulcer	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Xerosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Hepatobiliary disorders Jaundice	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Hepatobiliary disorders Ocular icterus	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Immune system disorders Allergy to arthropod sting	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Immune system disorders Hypersensitivity	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Beta haemolytic streptococcal infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Bronchitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations COVID-19	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Candida infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Cellulitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Conjunctivitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Coronavirus infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Coxsackie viral infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Device related infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Ear infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Enterocolitis infectious	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Enterovirus infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Epstein-Barr virus infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Escherichia urinary tract infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Eye infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Folliculitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	31.6% 6/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Fungal infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Fungal skin infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Furuncle	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Gastroenteritis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Gastroenteritis bacterial	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Gastroenteritis viral	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Gastrointestinal infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Gingivitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Herpes dermatitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Herpes simplex	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Herpes virus infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Herpes zoster	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Hordeolum	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Impetigo	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Infected bite	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Infected skin ulcer	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Influenza	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Laryngitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Localised infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Lower respiratory tract infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Lymph gland infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Mucosal infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Nail infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Nasal vestibulitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Nasopharyngitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Onychomycosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Oral candidiasis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Oral herpes	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Otitis externa	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Otitis media	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Otitis media acute	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Paronychia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	84.2% 16/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	83.3% 10/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	75.0% 12/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	70.0% 7/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	70.0% 7/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	66.7% 2/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 6/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Parotitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Pharyngitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Pharyngitis streptococcal	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Pneumonia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Post procedural infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Pustule	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Rash pustular	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	26.3% 5/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.8% 3/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Respiratory tract infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Respiratory tract infection bacterial	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Rhinitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Rhinovirus infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Sinusitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Skin bacterial infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Skin candida	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Skin infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.8% 3/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Staphylococcal infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Staphylococcal skin infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Stoma site infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Tinea capitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Tinea faciei	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Tinea infection	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Tinea pedis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Tonsillitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Tooth infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Tracheitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	31.6% 6/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 6/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Urinary tract infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Varicella	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Viral infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Viral pharyngitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Viral rhinitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Wound sepsis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Fracture	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Gastrostomy tube site complication	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Incision site pruritus	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Limb injury	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Nasal injury	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Overdose	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Scar	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Scratch	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Skin abrasion	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Tongue injury	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Venomous sting	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	31.2% 5/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Albumin urine present	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Anion gap decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	42.1% 8/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	43.8% 7/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	27.3% 3/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	60.0% 6/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 3/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 5/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Bacterial test positive	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood albumin decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	26.3% 5/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood bicarbonate decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood bicarbonate increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood chloride increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood creatinine increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	45.5% 5/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood glucose increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood urea decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood urea increased	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Body temperature fluctuation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Ejection fraction decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Electrocardiogram ST-T segment abnormal	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Electrocardiogram T wave amplitude decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations End-tidal CO2 decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Grip strength decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Haematocrit increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Haemoglobin decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Haemoglobin increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Lung diffusion test decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Lymphocyte count decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Lymphocyte count increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Lymphocyte percentage decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Neutrophil count decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Neutrophil percentage increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Nitrite urine present	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Platelet count decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Protein total decreased	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Protein urine	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Red blood cell count decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Red blood cells urine	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Red blood cells urine positive	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Specific gravity urine increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Staphylococcus test positive	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Urine ketone body present	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Urine leukocyte esterase positive	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Urine output decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Weight decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Weight increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	26.3% 5/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 5/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations White blood cell count decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	27.3% 3/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations White blood cell count increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations White blood cells urine positive	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations pH urine increased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Alkalosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	57.9% 11/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	31.2% 5/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 4/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hyperchloraemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	27.3% 3/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 4/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	26.3% 5/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	26.3% 5/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 6/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	36.4% 4/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	44.4% 4/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	41.7% 5/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.8% 3/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	44.4% 4/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	27.3% 3/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypophagia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	27.3% 3/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Obesity	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Salt craving	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	26.3% 5/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.8% 3/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	44.4% 4/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 4/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Kyphosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Muscle swelling	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal deformity	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	36.8% 7/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.8% 3/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Spinal deformity	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Toe walking	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Allodynia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Aphasia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Ataxia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Aura	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Depressed level of consciousness	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Disturbance in attention	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Dizziness	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 4/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Dysarthria	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Dysgeusia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Dyskinesia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Facial paralysis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Headache	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	57.9% 11/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	31.2% 5/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	44.4% 4/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	45.0% 9/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Horner's syndrome	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Hydrocephalus	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Lethargy	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Memory impairment	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Movement disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Muscle spasticity	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Nystagmus	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Paraesthesia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Sciatica	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Seizure	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Somnolence	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Syncope	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Tremor	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Nervous system disorders Visual field defect	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Abnormal behaviour	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Agitation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Anxiety	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Attention deficit hyperactivity disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Confusional state	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Delirium	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Depression	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Dyssomnia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Enuresis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Initial insomnia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Insomnia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Irritability	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Mood altered	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Obsessive-compulsive disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Psychiatric disorders Restlessness	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Albuminuria	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Crystalluria	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Cystitis noninfective	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Dysuria	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Glycosuria	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Haematuria	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	44.4% 4/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Proteinuria	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	27.3% 3/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Urethritis noninfective	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Urinary incontinence	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Urinary retention	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Renal and urinary disorders Urine abnormality	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Reproductive system and breast disorders Perineal rash	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Reproductive system and breast disorders Vulvovaginal discomfort	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	36.8% 7/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 6/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	44.4% 4/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 8/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	60.0% 6/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	47.4% 9/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 8/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 5/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Nasal inflammation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Nasal odour	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Snoring	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 3/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Acne	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	36.8% 7/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	37.5% 6/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 2/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	31.6% 6/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	62.5% 10/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	66.7% 2/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	44.4% 4/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 8/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Dermatosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	63.2% 12/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	83.3% 10/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	37.5% 6/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	36.4% 4/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	70.0% 7/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	60.0% 6/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	66.7% 2/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	55.6% 5/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 3/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 8/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Eczema	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	42.1% 8/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	41.7% 5/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	56.2% 9/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Eczema nummular	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	26.3% 5/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	31.2% 5/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Hair colour changes	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Hair texture abnormal	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Hand dermatitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Hypertrichosis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Keratosis pilaris	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Livedo reticularis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Macule	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Palmar erythema	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Papule	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Plantar erythema	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	26.3% 5/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Pseudofolliculitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	47.4% 9/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	41.7% 5/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 8/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	36.4% 4/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	60.0% 6/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	100.0% 3/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	66.7% 6/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Rash follicular	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	9.1% 1/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	66.7% 2/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.8% 3/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 4/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 2/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 6/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	50.0% 5/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	21.1% 4/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.8% 3/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	40.0% 4/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Seborrhoea	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin depigmentation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	30.0% 3/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin fragility	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	20.0% 2/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin lesion	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	12.5% 2/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin toxicity	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 4/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Telangiectasia	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	33.3% 1/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	15.0% 3/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Surgical and medical procedures Central venous catheter removal	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Surgical and medical procedures Tonsillectomy	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	16.7% 1/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Flushing	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 2/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Haematoma	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.0% 1/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Hypertension	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	6.2% 1/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.2% 2/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Hypotension	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.5% 2/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	25.0% 3/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	18.8% 3/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	22.2% 2/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Lymphoedema	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Pallor	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	5.3% 1/19 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	8.3% 1/12 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/16 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/11 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	10.0% 1/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/3 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	11.1% 1/9 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/6 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/20 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/10 • From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER