Trial Outcomes & Findings for Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 (NCT NCT02655601)

Last Updated: 2025-06-08

Results Overview

This was a dose escalation study in which patients were enrolled to receive 1 of 4 doses in dose ascending order. MTD was defined as the dose level that has an estimated DLT rate nearest to 0.25. This is applicable to the Phase 1 part of the study only. Note that an actual MTD was not reached, however a Phase 2 recommended dose was selected based on the dose that was most tolerable to patients.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

177 participants

Primary outcome timeframe

From the time the subject signs the informed consent form through 30 days after completion of the final BMX-001 treatment (up to approximately 16 weeks)

Results posted on

2025-06-08

Participant Flow

17 subjects were enrolled at 1 center for Phase 1. For Phase 2, 160 subjects were enrolled at 9 clinical centers in the US (mostly comprising university and top tier HGG treatment facilities.)

Phase 1 was a dose escalation study. Phase 1 participants did not participate in Phase 2. In Phase 2, patients were considered to have completed treatment in Arm A if they completed SOC chemoradiation and received the study drug, BMX-001 for at least 6 weeks, or 13 doses. In Arm B, patients were considered to have completed treatment if they completed SOC chemoradiation.

Participant milestones

Participant milestones
Measure	Phase 1 BMX-001 7 mg Loading Dose/3.5 mg Biw Dose BMX-001 was administered subcutaneously as a loading dose before starting concurrent standard of care chemoradiation. After the loading dose, the dose levels were given two times per week for 8 weeks. The starting dose level was a 7 mg loading dose followed by 3.5 mg maintenance doses twice a week for up to 8 weeks.	Phase 1 BMX-001 14 mg Loading Dose/7 mg Biw Dose BMX-001 was administered subcutaneously as a loading dose before starting concurrent standard of care chemoradiation. After the loading dose, the dose levels were given two times per week for 8 weeks. The second dose level was a 14 mg loading dose followed by 7 mg maintenance doses twice a week for up to 8 weeks.	Phase 1 BMX-001 28 mg Loading Dose/14 mg Biw Dose BMX-001 was administered subcutaneously as a loading dose before starting concurrent standard of care chemoradiation. After the loading dose, the dose levels were given two times per week for 8 weeks. The third dose level was a 28 mg loading dose followed by 14 mg maintenance doses twice a week for up to 8 weeks.	Phase 1 BMX-001 42 mg Loading Dose/20 mg Biw Dose BMX-001 was administered subcutaneously as a loading dose before starting concurrent standard of care chemoradiation. After the loading dose, the dose levels were given two times per week for 8 weeks. The fourth dose level was a 42 mg loading dose followed by 20 mg maintenance doses twice a week for up to 8 weeks.	Ph 2 Radiation Therapy, TMZ and BMX-001 Patients received standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks. A total of 80 subjects were eligible to receive BMX-001 in this phase.	Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Overall Study STARTED	4	3	6	4	80	80
Overall Study COMPLETED	3	3	6	3	74	71
Overall Study NOT COMPLETED	1	0	0	1	6	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 BMX-001 7 mg Loading Dose/3.5 mg Biw Dose BMX-001 was administered subcutaneously as a loading dose before starting concurrent standard of care chemoradiation. After the loading dose, the dose levels were given two times per week for 8 weeks. The starting dose level was a 7 mg loading dose followed by 3.5 mg maintenance doses twice a week for up to 8 weeks.	Phase 1 BMX-001 42 mg Loading Dose/20 mg Biw Dose BMX-001 was administered subcutaneously as a loading dose before starting concurrent standard of care chemoradiation. After the loading dose, the dose levels were given two times per week for 8 weeks. The fourth dose level was a 42 mg loading dose followed by 20 mg maintenance doses twice a week for up to 8 weeks.	Ph 2 Radiation Therapy, TMZ and BMX-001 Patients received standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks. A total of 80 subjects were eligible to receive BMX-001 in this phase.	Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Overall Study Adverse Event	0	1	1	0
Overall Study Physician Decision	0	0	1	1
Overall Study Withdrawal by Subject	0	0	4	8
Overall Study Treatment delayed too long per protocol due to adverse events	1	0	0	0

Baseline Characteristics

This measurement was not in existence for Phase 1 and is only applicable to Phase 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 Dose Level 1: Radiation Therapy, TMZ and BMX-001, All Patients Received BMX-001 n=4 Participants Dose escalation study. Patients received standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 7 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks.	Phase 1 Dose Level 2: Radiation Therapy, TMZ and BMX-001, All Patients Received BMX-001 n=3 Participants Dose escalation study. Patients received standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 14 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks.	Phase 1 Dose Level 3: Radiation Therapy, TMZ and BMX-001, All Patients Received BMX-001 n=6 Participants Dose escalation study. Patients received standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks.	Phase 1 Dose Level 4: Radiation Therapy, TMZ and BMX-001, All Patients Received BMX-001 n=4 Participants Dose escalation study. Patients received standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of42 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks.	Arm A: Ph 2 Radiation Therapy, TMZ and BMX-001 n=80 Participants Patients received standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks. A total of 80 subjects were eligible to receive BMX-001 in this phase.	Arm B: Ph 2 Radiation Therapy and TMZ n=80 Participants In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Total n=177 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 13.1 • n=4 Participants	61.3 years STANDARD_DEVIATION 2.1 • n=3 Participants	64.3 years STANDARD_DEVIATION 8.8 • n=6 Participants	50 years STANDARD_DEVIATION 24.7 • n=4 Participants	52.69 years STANDARD_DEVIATION 13.55 • n=80 Participants	54.39 years STANDARD_DEVIATION 14.23 • n=80 Participants	53.54 years STANDARD_DEVIATION 13.88 • n=177 Participants
Sex: Female, Male Female	2 Participants n=4 Participants	1 Participants n=3 Participants	4 Participants n=6 Participants	1 Participants n=4 Participants	35 Participants n=80 Participants	25 Participants n=80 Participants	68 Participants n=177 Participants
Sex: Female, Male Male	2 Participants n=4 Participants	2 Participants n=3 Participants	2 Participants n=6 Participants	3 Participants n=4 Participants	45 Participants n=80 Participants	55 Participants n=80 Participants	109 Participants n=177 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	1 Participants n=80 Participants	3 Participants n=80 Participants	4 Participants n=177 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=4 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants	4 Participants n=4 Participants	79 Participants n=80 Participants	76 Participants n=80 Participants	172 Participants n=177 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=80 Participants	1 Participants n=80 Participants	1 Participants n=177 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=80 Participants	0 Participants n=80 Participants	0 Participants n=177 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	3 Participants n=80 Participants	4 Participants n=80 Participants	7 Participants n=177 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=80 Participants	0 Participants n=80 Participants	0 Participants n=177 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	1 Participants n=4 Participants	1 Participants n=80 Participants	2 Participants n=80 Participants	4 Participants n=177 Participants
Race (NIH/OMB) White	4 Participants n=4 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants	3 Participants n=4 Participants	75 Participants n=80 Participants	72 Participants n=80 Participants	163 Participants n=177 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	1 Participants n=80 Participants	2 Participants n=80 Participants	3 Participants n=177 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=80 Participants	0 Participants n=80 Participants	0 Participants n=177 Participants
Region of Enrollment United States	4 participants n=4 Participants	3 participants n=3 Participants	6 participants n=6 Participants	4 participants n=4 Participants	80 participants n=80 Participants	80 participants n=80 Participants	177 participants n=177 Participants
WHO 2021 Histology Glioblastoma, IDH-wildtype	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	55 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	56 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	111 Participants n=160 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2
WHO 2021 Histology Astrocytoma, IDH-mutant	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	17 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	15 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	32 Participants n=160 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2
WHO 2021 Histology Oligodendroglioma, IDH-mutant, and 1p/19q-codeleted	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	4 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	6 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	10 Participants n=160 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2
WHO 2021 Histology Glioblastoma, NOS	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	2 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	1 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	3 Participants n=160 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2
WHO 2021 Histology Glioblastoma, IDH-wildtype, gliosarcoma subtype	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	1 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	1 Participants n=160 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2
WHO 2021 Histology Ganglioglioma	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	1 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	1 Participants n=160 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2
WHO 2021 Histology Glioblastoma, IDH-wildtype, giant cell subtype	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	1 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	1 Participants n=160 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2
WHO 2021 Histology Pleomorphic Xanthoastrocytoma	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants This measurement was not in existence for Phase 1 and is only applicable to Phase 2	1 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	0 Participants n=80 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2	1 Participants n=160 Participants • This measurement was not in existence for Phase 1 and is only applicable to Phase 2
WHO 2021 Tumor Grade Grade 4	0 Participants This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2	0 Participants This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2	0 Participants This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2	0 Participants This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2	65 Participants n=80 Participants • This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2	67 Participants n=80 Participants • This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2	132 Participants n=160 Participants • This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2
WHO 2021 Tumor Grade Grade 3	0 Participants This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2	0 Participants This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2	0 Participants This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2	0 Participants This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2	15 Participants n=80 Participants • This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2	13 Participants n=80 Participants • This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2	28 Participants n=160 Participants • This measurement for 2021 WHO grading was not applicable at the time of Phase 1, and only works for Phase 2
WHO 2016 Histology Glioblastoma Multiforme	3 Participants n=4 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants	4 Participants n=4 Participants	61 Participants n=80 Participants	64 Participants n=80 Participants	141 Participants n=177 Participants
WHO 2016 Histology Anaplastic astrocytoma	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	11 Participants n=80 Participants	7 Participants n=80 Participants	18 Participants n=177 Participants
WHO 2016 Histology Anaplastic oligodendroglioma	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	4 Participants n=80 Participants	6 Participants n=80 Participants	10 Participants n=177 Participants
WHO 2016 Histology Giant Cell Glioblastoma	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	2 Participants n=80 Participants	0 Participants n=80 Participants	2 Participants n=177 Participants
WHO 2016 Histology Anaplastic ganglioglioma	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=80 Participants	1 Participants n=80 Participants	1 Participants n=177 Participants
WHO 2016 Histology Gliosarcoma	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=80 Participants	1 Participants n=80 Participants	1 Participants n=177 Participants
WHO 2016 Histology High Grade Astrocytoma, NOS	1 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	1 Participants n=80 Participants	0 Participants n=80 Participants	2 Participants n=177 Participants
WHO 2016 Histology Other, Specify	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=80 Participants	1 Participants n=80 Participants	1 Participants n=177 Participants
WHO 2016 Histology Pleomorphic xanthoastrocytoma	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	1 Participants n=80 Participants	0 Participants n=80 Participants	1 Participants n=177 Participants
WHO 2016 Classification (WHO CNS4) WHO 2016 Grade 4	3 Participants n=4 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants	4 Participants n=4 Participants	62 Participants n=80 Participants	66 Participants n=80 Participants	144 Participants n=177 Participants
WHO 2016 Classification (WHO CNS4) WHO 2016 Grade 3	1 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	18 Participants n=80 Participants	14 Participants n=80 Participants	33 Participants n=177 Participants
KPS KPS score 90	2 Participants n=4 Participants	1 Participants n=3 Participants	4 Participants n=6 Participants	1 Participants n=4 Participants	39 Participants n=80 Participants	37 Participants n=80 Participants	84 Participants n=177 Participants
KPS KPS score 80	1 Participants n=4 Participants	1 Participants n=3 Participants	0 Participants n=6 Participants	3 Participants n=4 Participants	22 Participants n=80 Participants	25 Participants n=80 Participants	52 Participants n=177 Participants
KPS KPS score 100	0 Participants n=4 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants	0 Participants n=4 Participants	19 Participants n=80 Participants	11 Participants n=80 Participants	31 Participants n=177 Participants
KPS KPS score 70	1 Participants n=4 Participants	1 Participants n=3 Participants	1 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=80 Participants	7 Participants n=80 Participants	10 Participants n=177 Participants

PRIMARY outcome

Timeframe: From the time the subject signs the informed consent form through 30 days after completion of the final BMX-001 treatment (up to approximately 16 weeks)

Population: All patients who received at least 1 dose of BMX-001, regardless of dose level, after enrolling on study.

Outcome measures

Outcome measures
Measure	Phase 1 n=17 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 1: Maximum Tolerated Dose (MTD) of BMX-001 Administered in Combination With Standard RT and TMZ in Newly Diagnosed HGG Patients	NA mg/Participant MTD was not reached	—	—

PRIMARY outcome

Timeframe: From the time between randomization and death, or the date of last follow-up if the patient remains alive. Per protocol, patients will be followed indefinitely

Population: All enrolled participants enrolled in Phase 2 were included in the analysis. This was not a primary objective of Phase 1.

This is applicable for Phase 2 only. It was a secondary objective of Phase 1 and that is reported as a separate outcome measure. Assessment of overall survival. With standard treatment, the median survival of Grade IV patients is expected to be 14.6 months, and the median survival of Grade III is approximately 36 months. Given that we anticipate that approximately 10% of patients to be Grade III, we estimate that the overall median survival with standard treatment to be roughly 16.7 months.

Outcome measures

Outcome measures
Measure	Phase 1 n=80 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ n=80 Participants In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 2: Overall Survival, Intent to Treat (ITT) Population	32.2 months Interval 21.8 to Upper confidence interval was not reached	27.6 months Interval 19.8 to 33.8	—

SECONDARY outcome

Timeframe: From the time between enrollment and death, or the date of last follow-up if the patient remains alive.

Population: This analysis includes all participants enrolled. A Kaplan-Meier analysis is not appropriate for very small groups in each dose escalation cohort because the statistical power would be insufficient, leading to unreliable survival estimates. According to the study statistical analysis plan, OS will be assessed for all participants enrolled in Phase 1 as a whole, rather than separately by dose level.

Median Overall Survival (OS) is a key clinical outcome measure used to assess the efficacy of BMX-001 in combination with standard radiotherapy (RT) and temozolomide (TMZ) in patients with newly diagnosed high-grade gliomas (HGG). OS is defined as the time from the date of study enrollment to the date of death from any cause. Survival status was assessed at regular follow-up intervals (e.g., every 3 months post-treatment) through medical records, patient contact, and clinical evaluations. The final analysis was conducted after a pre-specified number of events (deaths) have occurred. Expected Outcome: Prolonged median OS compared to historical or control data (RT + TMZ alone) would suggest a survival benefit associated with BMX-001.

Outcome measures

Outcome measures
Measure	Phase 1 n=17 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 1: Median Overall Survival	22.2 Months Interval 11.2 to 24.7	—	—

SECONDARY outcome

Timeframe: From the time the subject signs the informed consent form through 30 days after completion of the final BMX-001 treatment (up to approximately 16 weeks)

Population: All patients who received at least 1 dose of BMX-001, regardless of dose level, after enrolling on study.

This is only applicable for the Phase 1 portion of the study. All patients who received at least 1 dose of BMX-001, regardless of dose level, after enrolling on study are included in the analysis.

Outcome measures

Outcome measures
Measure	Phase 1 n=17 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 1: Number of Participants Who Experiences a Dose-limiting Toxicity (DLT). BMX-001: 28 mg loading dose / 14 mg biw dose	0 Participants	—	—
Phase 1: Number of Participants Who Experiences a Dose-limiting Toxicity (DLT). BMX-001: 14 mg loading dose / 7 mg biw dose	0 Participants	—	—
Phase 1: Number of Participants Who Experiences a Dose-limiting Toxicity (DLT). BMX-001: 7 mg loading dose / 3.5 mg biw dose	0 Participants	—	—
Phase 1: Number of Participants Who Experiences a Dose-limiting Toxicity (DLT). BMX-001: 42 mg loading dose / 20 mg biw dose	1 Participants	—	—

SECONDARY outcome

Timeframe: From the time the subject signs the informed consent form through 6 months after completion of the final BMX-001 treatment (up to approximately 40 weeks)

Population: Only 6 out of 17 eligible participants completed COWAT assessments at the time this objective was measured 24 weeks after the end of standard of care Radiotherapy + Temozolomide.

The Controlled Oral Word Association Test (COWAT) measures verbal fluency which reflects executive functioning, processing speed, mental flexibility, and language output. The raw score is then adjusted for age, education, and normative data to allow meaningful comparisons across individuals. The standardized score (T-score) is calculated using normative reference tables. Higher Scores = Better Cognitive Function, lower scores = cognitive impairment. T score range is 0-100. A T-score of 50 represents the mean performance in the normative population, this means a score of 50 indicates the population mean performance with a standard deviation of 10. T-scores below 40 suggest clinically significant cognitive decline. Scores range from \< 30 (significantly below average), to 30-39 (below average), 40-59 (average), and greater than or equal to 60 is above average. Stable or improved COWAT scores over time would suggest that adding BMX-001 may help preserve cognitive function.

Outcome measures

Outcome measures
Measure	Phase 1 n=6 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Adjusted Change T Score Achieved on the Controlled Oral Word Association Test (COWAT). BMX-001: 7 mg loading dose / 3.5 mg biw dose	4 T-score Standard Deviation NA Sample size is 1	—	—
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Adjusted Change T Score Achieved on the Controlled Oral Word Association Test (COWAT). BMX-001: 14 mg loading dose / 7 mg biw dose	-3 T-score Standard Deviation NA Sample size is 1	—	—
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Adjusted Change T Score Achieved on the Controlled Oral Word Association Test (COWAT). BMX-001: 28 mg loading dose / 14 mg biw dose	2 T-score Standard Deviation 9.6	—	—
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Adjusted Change T Score Achieved on the Controlled Oral Word Association Test (COWAT). BMX-001: 42 mg loading dose / 20 mg biw dose	22 T-score Standard Deviation NA Sample size is 1	—	—

SECONDARY outcome

Timeframe: From the time the subject signs the informed consent form through 6 months after completion of the final BMX-001 treatment (up to approximately 40 weeks)

Population: Only 6 out of 17 eligible participants completed Trail Making Test (TMT): Part A assessments at the time this objective was measured 24 weeks after the end of standard of care Radiotherapy + Temozolomide.

Part A of the Trails Making Test (TMT) measures visual attention and processing speed by requiring the patient to connect numbers sequentially (1 → 2 → 3, etc.) as quickly as possible. This is a widely used neuropsychological test that measures visual attention, processing speed, and psychomotor function. Raw scores are measured in seconds (time to complete the task), but T-scores are derived by converting time-based results into a normed distribution accounting for age and education. Mean (SD) change in cognitive assessment in T-Scores is reported and the range is 0-100. T score interpretation and range is \< 30 (significantly impaired), 30-39 (mildly impaired), 40-59 (Average), \>/= 60 (Above average). A T-score of 50 represents the mean performance in the normative population, this means a score of 50 indicates the population mean performance with a standard deviation of 10. Higher scores = better performance.

Outcome measures

Outcome measures
Measure	Phase 1 n=6 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Score Achieved on the Trails Making Test (TMT): Part A BMX-001: 7 mg loading dose / 3.5 mg biw dose	-0.4 T-Score Standard Deviation NA Sample size is 1	—	—
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Score Achieved on the Trails Making Test (TMT): Part A BMX-001: 14 mg loading dose / 7 mg biw dose	5.1 T-Score Standard Deviation NA Sample size is 1	—	—
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Score Achieved on the Trails Making Test (TMT): Part A BMX-001: 28 mg loading dose / 14 mg biw dose	0.9 T-Score Standard Deviation 0.4	—	—
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Score Achieved on the Trails Making Test (TMT): Part A BMX-001: 42 mg loading dose / 20 mg biw dose	3.1 T-Score Standard Deviation NA Sample size is 1	—	—

SECONDARY outcome

Timeframe: From the time the subject signs the informed consent form through 6 months after completion of the final BMX-001 treatment (up to approximately 40 weeks)

Population: Only 6 out of 17 eligible participants completed Trail Making Test (TMT): Part B assessments at the time this objective was measured 24 weeks after the end of standard of care Radiotherapy + Temozolomide.

The Trails Making Test (TMT) Part B is a widely used neuropsychological test that measures set-shifting ability, processing speed, and working memory. While Part A focuses on speed, visual scanning, and attention. Prolonged completion time or an increase in errors compared to baseline or age-adjusted norms would indicate cognitive decline. Raw scores are measured in seconds (time to complete the task), but T-scores are derived by converting time-based results into a normed distribution accounting for age and education. Mean (SD) change in T score is reported, range is 0-100. T score interpretation and range is \< 30 (significantly impaired), 30-39 (mildly impaired), 40-59 (Average), \>/= 60 (Above average). A T-score of 50 represents the mean performance in the normative population, this means a score of 50 indicates the population mean performance with a standard deviation of 10. Higher scores = better performance.

Outcome measures

Outcome measures
Measure	Phase 1 n=6 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Score Achieved on the Trail Making Test (TMT): Part B BMX-001: 28 mg loading dose / 14 mg biw dose	-0.3 T-score Standard Deviation 1	—	—
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Score Achieved on the Trail Making Test (TMT): Part B BMX-001: 42 mg loading dose / 20 mg biw dose	1 T-score Standard Deviation NA Sample size is 1	—	—
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Score Achieved on the Trail Making Test (TMT): Part B BMX-001: 7 mg loading dose / 3.5 mg biw dose	0.3 T-score Standard Deviation NA Sample size is 1	—	—
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Score Achieved on the Trail Making Test (TMT): Part B BMX-001: 14 mg loading dose / 7 mg biw dose	7.1 T-score Standard Deviation NA Sample size is 1	—	—

SECONDARY outcome

Timeframe: From the time the subject signs the informed consent form through 6 months after completion of the final BMX-001 treatment (up to approximately 40 weeks)

Population: Only 6 out of 17 eligible participants completed HVLT-R assessments at the time this objective was measured 24 weeks after the end of standard of care Radiotherapy + Temozolomide.

Hopkins Verbal Learning Test- Revised (HVLT-R) is a standardized neuropsychological assessment that measures verbal learning and memory, including total (immediate recall). Total Recall T-score is derived from the sum of correctly recalled words across three learning trials and is normalized based on age-adjusted normative data. This provides insight into immediate verbal memory performance and learning ability. Total Recall (Immediate Memory \& Learning) is Sum of correctly recalled words across three learning trials and is a measurement of immediate recall capacity and learning efficiency. Raw score range is 0-36, T score range is 0-100. T scores \>/= 60 are above average and T scores \< 40 are below average. A T-score of 50 represents the mean performance in the normative population, this means a score of 50 indicates the population mean with a standard deviation of 10

Outcome measures

Outcome measures
Measure	Phase 1 n=6 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Total Recall Change T-score Achieved on the Hopkins Verbal Learning Test- Revised (HVLT-R) BMX-001: 14 mg loading dose / 7 mg biw dose	-5 T-Score Standard Deviation NA Sample size is 1	—	—
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Total Recall Change T-score Achieved on the Hopkins Verbal Learning Test- Revised (HVLT-R) BMX-001: 7 mg loading dose / 3.5 mg biw dose	17 T-Score Standard Deviation NA Sample size is 1	—	—
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Total Recall Change T-score Achieved on the Hopkins Verbal Learning Test- Revised (HVLT-R) BMX-001: 28 mg loading dose / 14 mg biw dose	-1 T-Score Standard Deviation 11.4	—	—
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Total Recall Change T-score Achieved on the Hopkins Verbal Learning Test- Revised (HVLT-R) BMX-001: 42 mg loading dose / 20 mg biw dose	19 T-Score Standard Deviation NA Sample size is 1	—	—

SECONDARY outcome

Timeframe: Adverse events occurring from baseline through 30 days post completion of treatment (approximately 12 weeks total).

Population: This analysis focuses on the proportion of patients who experience any grade 3 or 4 adverse event during radiation and temozolomide treatment. This outcome measure does not apply to the Phase 1 portion of the study, as it was not designated as an outcome for Phase 1 but was specified only for Phase 2.

To assess the safety and tolerability of standard RT and TMZ in combination with BMX-001 compared to standard RT and TMZ alone in newly diagnosed HGG patients. The phase 2 portion of this study has two adverse event endpoints: 1. The proportion of patients who experience any grade 3 or 4 adverse event during radiation and temozolomide treatment, and 2. The proportion of patients who experience a grade 3 or 4 adverse event that is definitely, possibly, or probably related to BMX-001 treatment during this same period. This outcome measure does not apply to the Phase 1 portion of the study, as it was not designated as an outcome for Phase 1 but was specified only for Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 n=80 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ n=80 Participants In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 2: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	17 Participants	13 Participants	—

SECONDARY outcome

Timeframe: Adverse events occurring from baseline through 30 days post completion of treatment (approximately 12 weeks total).

Population: This outcome measure does not apply to the Phase 1 portion of the study, as it was not designated as an outcome for Phase 1 but was specified only for Phase 2. This analysis focuses on the proportion of patients who experience a grade 3 or 4 adverse event that is definitely, possibly, or probably related to BMX-001 treatment during this same period. Data is only presented for Arm A, the BMX-001 treatment group, as subjects in Arm B did not receive BMX-001.

To assess the safety and tolerability of standard RT and TMZ in combination with BMX-001 compared to standard RT and TMZ alone in newly diagnosed HGG patients. This outcome is measured to test the proportion of patients who experience a grade 3 or 4 adverse event that is definitely, possibly, or probably related to BMX-001 treatment during this same period. This outcome measure does not apply to the Phase 1 portion of the study, as it was not designated as an outcome for Phase 1 but was specified only for Phase 2. It also only applies to Arm A in the study as Arm B did not receive the study drug.

Outcome measures

Outcome measures
Measure	Phase 1 n=80 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 2: Incidence of Treatment-Emergent Adverse Events Related to BMX-001	5 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Only patients that had both a baseline + follow up tests completed could be included in the analysis

Hopkins Verbal Learning Test- Revised (HVLT-R) is a standardized neuropsychological test that measures verbal learning and memory, including total (immediate recall), delayed recall, and recognition discrimination. It is scored using a T-score which are calculated based on raw scores (e.g., number of words recalled) and standardized using normative data adjusted for age, education, and sometimes sex. T-score range is 0-100. T-scores \>/= 60 are above average and T scores \< 40 are below average. Higher scores are better. Total recall interpretation - T ≥ 60: above average; T \< 40: below average. Delayed recall - T \< 30 may suggest memory consolidation issues, and recognition discrimination - T \< 30 may indicate impaired recognition memory. A T-score of 50 represents the mean performance in the normative population, this means a score of 50 indicates the population mean performance with a standard deviation of 10. Mean (SD) change in cognitive assessment is reported.

Outcome measures

Outcome measures
Measure	Phase 1 n=80 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ n=80 Participants In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 2: Protection/Improvement of Cognition Using Hopkins Verbal Learning-Revised HVLT-R Delayed Recall T Score: Mean Changes from Baseline at Week 24 (+/-4 Wks) Post-radrx Compltion	0.45 T-Score Standard Deviation 13.18	-4.07 T-Score Standard Deviation 8.61	—
Phase 2: Protection/Improvement of Cognition Using Hopkins Verbal Learning-Revised HVLT-R Recognition Index T Score: Mean Changes from Bseline at Wk 24 (+/-4 Wks) Post-radrx Compltion	-2.14 T-Score Standard Deviation 13.81	2.79 T-Score Standard Deviation 11.77	—
Phase 2: Protection/Improvement of Cognition Using Hopkins Verbal Learning-Revised HVLT-R Retention T Score: Mean Changes from Baseline at Week 24 (+/-4 Weeks) Post-radrx Completion	1.79 T-Score Standard Deviation 15.49	-2.29 T-Score Standard Deviation 16.06	—
Phase 2: Protection/Improvement of Cognition Using Hopkins Verbal Learning-Revised HVLT-R Total Recall T Score: Mean Changes from Baseline at Week 24 (+/-4 Wks) Post-radrx Completion	2 T-Score Standard Deviation 9.82	0.07 T-Score Standard Deviation 13.85	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Only patients that had both a baseline + follow up tests completed could be included in the analysis

This Controlled Oral Word Association Test (COWAT) measure verbal fluency which reflects executive functioning, processing speed, mental flexibility, and language output. The raw score is adjusted for age, education, and normative data to allow meaningful comparisons across individuals. The standardized score (T-score) is calculated using normative reference tables. Higher Scores = Better Cognitive Function, lower scores = cognitive impairment. T-score range is 0-100 A T-score of 50 represents the mean performance in the normative population, this means a score of 50 indicates the population mean performance with a standard deviation of 10. T-scores below 40 suggest clinically significant cognitive decline. Scores range from \< 30 (significantly below average), to 30-39 (below average), 40-59 (average), and greater than or equal to 60 is above average. Stable or improved COWAT scores over time would suggest that adding BMX-001 may help preserve cognition.

Outcome measures

Outcome measures
Measure	Phase 1 n=27 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ n=13 Participants In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 2: Protection/Improvement of Cognition Via the Controlled Oral Word Association Test (COWAT)	4.19 T-Score Standard Deviation 14.65	5.23 T-Score Standard Deviation 11.2	—

SECONDARY outcome

Timeframe: Baseline and Week 24 Baseline and Week 24 Baseline and Week 24

Population: Only patients that had both a baseline + follow up tests completed could be included in the analysis

Phase 1 is reported separately. Neurocognitive testing was done and reported here for the Trails Test A and B Part A: Visual attention and processing speed Part B: Executive functioning, task switching, and divided attention. Part A testing time is typically 20-90 sec, and Part B time is typically 40-180 sec. Raw scores are measured in seconds (time to complete the task), but T-scores are derived by converting time-based results into a normed distribution accounting for age and education. Mean (SD) change in cognitive assessment in T-Scores is reported T score interpretation and range is \< 30 (significantly impaired), 30-39 (mildly impaired), 40-59 (Average), \>/60 (above average) A T-score of 50 represents the mean performance in the normative population, this means a score of 50 indicates the population mean performance with a standard deviation of 10. Lower times = better

Outcome measures

Outcome measures
Measure	Phase 1 n=80 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ n=80 Participants In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 2: Protection/Improvement of Cognition - Trails Making Test A and B Trail A Completion Time: Mean Changes from Baseline at Week 24 (+/-4 Wks) Post-radiation Completion	-0.24 T Score Standard Deviation 2.08	2.37 T Score Standard Deviation 6.45	—
Phase 2: Protection/Improvement of Cognition - Trails Making Test A and B Trail B Completion Time: Mean Changes from Baseline at Week 24 (+/-4 Wks) Post-radiation Completion	.19 T Score Standard Deviation 1.33	2.29 T Score Standard Deviation 4.46	—

SECONDARY outcome

Timeframe: Approximately 12 weeks (from Baseline to 30 days post completion of treatment)

Population: For this endpoint to have relevance, a patient must have received some treatment with temozolomide and radiation in either Arm A or B. Analyses suggest that 78 patients in Arm A and 71 patients in Arm B received at least some form of protocol treatment.

This was not a secondary outcome in Phase 1 and therefore only applies to Phase 2. The proportion of patients who experience grade 3 or 4 thrombocytopenia during concurrent temozolomide and radiation will be recorded within each treatment group. The proportion of patients who experience a platelet count less than 100K during concurrent temozolomide and radiation will also be recorded within each treatment group. For both endpoints described above, a chi-square or Fisher's exact test was conducted to compare the prevalence of such thrombocytopenia observed in patients with and without BMX-001.

Outcome measures

Outcome measures
Measure	Phase 1 n=78 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ n=71 Participants In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 2: Protection of Bone Marrow Against Chemotherapy-Induced Thrombocytopenia	1 Participants	2 Participants	—

SECONDARY outcome

Timeframe: up to 5 years

Population: All patients enrolled in each specific arm

The primary analysis of PFS will consider all patients, and consider them in their assigned treatment arm regardless of compliance. This approach to analysis is consistent with an intent-to-treat analysis approach. Progression-Free Survival (PFS) is defined as the time from randomization (Phase 2) or study enrollment (Phase 1) to the first occurrence of either disease progression (as determined by standardized radiographic criteria, the RANO \[Response Assessment in Neuro-Oncology\] criteria) or death from any cause, whichever occurs first. Patients who have not experienced progression or death at the time of analysis will be censored at their last known follow-up date. PFS will be estimated using the Kaplan-Meier method, providing median PFS and corresponding 95% confidence intervals (CI).

Outcome measures

Outcome measures
Measure	Phase 1 n=17 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ n=80 Participants In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ n=80 Participants In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 1 and Phase 2: Progression-free Survival (PFS)	7.1 months Interval 3.9 to 11.4	11.9 months Interval 8.4 to 28.4	14.7 months Interval 9.6 to 28.5

SECONDARY outcome

Timeframe: 12 weeks

The guidelines and criteria for radiographic response will be based on the updated RANO criteria for newly diagnosed GBM. MRI brain with and without contrast will be obtained at enrollment, 2-4 weeks after standard RT and TMZ, and every 8 weeks during adjuvant TMZ. Since this is a study in newly diagnosed patients with HGG, the baseline imaging will be designated as the imaging obtained 2 to 4 weeks after the completion of standard RT and TMZ. At each time point, based on RANO criteria, the subject response will be characterized as Complete Response, Partial Response, Progressive Disease, Stable Disease, or Not Evaluable.

Outcome measures

Outcome measures
Measure	Phase 1 n=17 Participants All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\]) BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	ARm B: Ph 2 Radiation Therapy and TMZ n=80 Participants In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.	Arm B: Ph 2 Radiation Therapy and TMZ n=80 Participants In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm.
Phase 1 and 2: Complete or Partial Radiographic Response to Tumor	0 proportion of participants Interval 0.0 to 0.0	0.1125 proportion of participants Interval 0.0528 to 0.2028	0.0625 proportion of participants Interval 0.0206 to 0.1399

Adverse Events

Phase 1: BMX-001: 7 mg Loading Dose / 3.5 mg Biw Dose

Serious events: 0 serious events

Other events: 4 other events

Deaths: 3 deaths

Phase 1: BMX-001: 14 mg Loading Dose / 7 mg Biw Dose

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase 1: BMX-001: 28 mg Loading Dose / 14 mg Biw Dose

Serious events: 0 serious events

Other events: 6 other events

Deaths: 6 deaths

Phase 1: BMX-001: 42 mg Loading Dose / 20 mg Biw Dose

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

Arm A: Radiation Therapy, TMZ and BMX-001

Serious events: 11 serious events

Other events: 77 other events

Deaths: 41 deaths

Arm B: Radiation Therapy and TMZ

Serious events: 10 serious events

Other events: 70 other events

Deaths: 48 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1: BMX-001: 7 mg Loading Dose / 3.5 mg Biw Dose n=4 participants at risk The dose escalation study. Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 7 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks	Phase 1: BMX-001: 14 mg Loading Dose / 7 mg Biw Dose n=3 participants at risk The dose escalation study. Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 14 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks	Phase 1: BMX-001: 28 mg Loading Dose / 14 mg Biw Dose n=6 participants at risk The dose escalation study. Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks	Phase 1: BMX-001: 42 mg Loading Dose / 20 mg Biw Dose n=4 participants at risk The dose escalation study. Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of42 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks	Arm A: Radiation Therapy, TMZ and BMX-001 n=80 participants at risk Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 will be given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks. A total of 80 subjects will receive BMX-001 in this phase. BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	Arm B: Radiation Therapy and TMZ n=80 participants at risk In this arm, one-half of the study subjects will not receive BMX-001 but will undergo all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects will be in this study arm. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.
Cardiac disorders Dyspnoea	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Cardiac disorders Sinus tachycardia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Pancreatitis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Hepatobiliary disorders Cholecystitis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Immune system disorders Anaphylactic reaction	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Immune system disorders Hypersensitivity	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Neutrophil count decreased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Aphasia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Haemorrhage intracranial	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Seizure	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Surgical and medical procedures Surgery	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Vascular disorders Embolism	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Vomiting	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Brain oedema	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Headache	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Muscular weakness	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Pyramidal tract syndrome	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Hypotension	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years

Other adverse events

Other adverse events
Measure	Phase 1: BMX-001: 7 mg Loading Dose / 3.5 mg Biw Dose n=4 participants at risk The dose escalation study. Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 7 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks	Phase 1: BMX-001: 14 mg Loading Dose / 7 mg Biw Dose n=3 participants at risk The dose escalation study. Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 14 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks	Phase 1: BMX-001: 28 mg Loading Dose / 14 mg Biw Dose n=6 participants at risk The dose escalation study. Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks	Phase 1: BMX-001: 42 mg Loading Dose / 20 mg Biw Dose n=4 participants at risk The dose escalation study. Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of42 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks	Arm A: Radiation Therapy, TMZ and BMX-001 n=80 participants at risk Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 will be given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks. A total of 80 subjects will receive BMX-001 in this phase. BMX-001: BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.	Arm B: Radiation Therapy and TMZ n=80 participants at risk In this arm, one-half of the study subjects will not receive BMX-001 but will undergo all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects will be in this study arm. Radiation Therapy: RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Temozolomide: Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.
Investigations Lymphocyte count decreased	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	66.7% 4/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	30.0% 24/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	26.2% 21/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Lymphocyte percentage decreased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	8.8% 7/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	7.5% 6/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Aphasia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Granulocyte percentage	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Haematocrit decreased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Haematocrit increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Lipase	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Blood and lymphatic system disorders Anaemia	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	83.3% 5/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	27.5% 22/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	17.5% 14/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Cardiac disorders Palpitations	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Cardiac disorders Sinus tachycardia	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	21.2% 17/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Cardiac disorders Tachycardia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	10.0% 8/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Ear and labyrinth disorders Auditory disorder	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Ear and labyrinth disorders Ear congestion	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Ear and labyrinth disorders Ear disorder	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Ear and labyrinth disorders Ear pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Ear and labyrinth disorders Hypoacusis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Ear and labyrinth disorders Labyrinthitis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Ear and labyrinth disorders Middle ear disorder	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Ear and labyrinth disorders Otitis externa	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Ear and labyrinth disorders Otitis media	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Endocrine disorders Cushingoid	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Accommodation disorder	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Chalazion	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Dry eye	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Eye irritation	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Hordeolum	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Ocular hyperaemia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Pupillary disorder	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Quadrantanopia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Vision blurred	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Vitreous floaters	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Aphthous ulcer	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Constipation	75.0% 3/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 2/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	37.5% 30/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	37.5% 30/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	66.7% 2/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	12.5% 10/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	12.5% 10/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Dry mouth	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Flatulence	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Frequent bowel movements	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Hiccups	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Nausea	75.0% 3/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	66.7% 4/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	56.2% 45/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.8% 27/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Oesophageal pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Vomiting	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	13.8% 11/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	11.2% 9/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Asthenia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Chest pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Face oedema	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Fatigue	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	66.7% 2/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	83.3% 5/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	61.3% 49/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	51.2% 41/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Incision site pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Influenza like illness	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Injection site hypersensitivity	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Injection site papule	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Injection site urticaria	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Localised oedema	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Malaise	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Non-cardiac chest pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Oedema peripheral	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 3/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	8.8% 7/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Peripheral swelling	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Pyrexia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Hepatobiliary disorders Cholangitis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Hepatobiliary disorders Hepatotoxicity	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Immune system disorders Hypersensitivity	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	20.0% 16/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Candida infection	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Conjunctivitis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Fungal infection	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Helicobacter gastritis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Incision site infection	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Infection	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Lung infection	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Nail infection	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Rash pustular	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Sinusitis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Urinary tract infection	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 2/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Viral infection	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Wound infection	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Injection site erythema	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Injection site paraesthesia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Injection site pruritus	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Injection site reaction	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	100.0% 3/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 2/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	80.0% 64/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Injury	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Alanine aminotransferase	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Alanine aminotransferase increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 2/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	17.5% 14/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	11.2% 9/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Aspartate aminotransferase	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	66.7% 4/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	13.8% 11/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	13.8% 11/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Blood alkaline phosphatase	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Blood alkaline phosphatase increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Blood bilirubin	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Blood bilirubin increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Blood chloride increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Blood creatinine	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Blood creatinine increased	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Blood urea increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Cardiac murmur	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Electrocardiogram QT interval	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Electrocardiogram QT prolonged	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Granulocyte count increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	7.5% 6/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Mean cell haemoglobin concentration	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Neutrophil count decreased	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 2/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	7.5% 6/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Neutrophil count increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Neutrophil percentage increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Platelet count decreased	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	83.3% 5/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	23.8% 19/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	17.5% 14/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Platelet count increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Weight decreased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	8.8% 7/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Weight increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations White blood cell count decreased	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 3/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	8.8% 7/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	7.5% 6/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations White blood cell count increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	10.0% 8/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.2% 13/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	13.8% 11/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	66.7% 4/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	15.0% 12/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	15.0% 12/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 2/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 2/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Hypoglycaemia	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Hypokalaemia	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	66.7% 4/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	12.5% 10/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	8.8% 7/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	11.2% 9/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Oedema	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	7.5% 6/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Chills	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Amnesia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Ataxia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Cognitive disorder	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Disturbance in attention	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Dizziness	100.0% 4/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 3/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	12.5% 10/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Dysgeusia	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	10.0% 8/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	10.0% 8/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Encephalopathy	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Facial paralysis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Gait disturbance	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Head discomfort	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Headache	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	100.0% 3/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 2/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	22.5% 18/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 20/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Hemiparesis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Hypoaesthesia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Lethargy	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Memory impairment	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Muscle spasticity	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Muscular weakness	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	13.8% 11/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Nervous system disorder	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Neuropathy peripheral	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Orthostatic hypotension	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Paraesthesia	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	8.8% 7/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Pyramidal tract syndrome	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Seizure	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	50.0% 2/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	11.2% 9/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	8.8% 7/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Sensory loss	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Subdural hygroma	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Tinnitus	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 2/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Tremor	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	7.5% 6/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Visual field defect	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Agitation	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Anxiety	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	11.2% 9/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	8.8% 7/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Aphasia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Confusional state	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	7.5% 6/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	7.5% 6/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Depression	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Dysarthria	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Hallucination	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Hypersomnia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Insomnia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	66.7% 2/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	7.5% 6/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	10.0% 8/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Personality change	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Somnolence	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Suicidal ideation	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Renal and urinary disorders Pollakiuria	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Renal and urinary disorders Urinary incontinence	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Renal and urinary disorders Urinary tract pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Anosmia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	11.2% 9/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Nasal congestion	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Alopecia	75.0% 3/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	66.7% 2/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	83.3% 5/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	41.2% 33/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	32.5% 26/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Dry skin	75.0% 3/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	66.7% 2/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Injection site discolouration	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Injection site rash	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Keratosis pilaris	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 2/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	26.2% 21/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Purpura	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Radiation skin injury	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Scab	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Skin sensitisation	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	6.2% 5/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Surgical and medical procedures Cholecystectomy	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Surgical and medical procedures Constipation prophylaxis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Vascular disorders Deep vein thrombosis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Vascular disorders Embolism	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Vascular disorders Flushing	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	7.5% 6/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Vascular disorders Hypertension	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	10.0% 8/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Vascular disorders Hypotension	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	3.8% 3/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Vascular disorders Thrombophlebitis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Cardiac disorders Chest pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Ear and labyrinth disorders Barotitis media	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Ear and labyrinth disorders External ear inflammation	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Conjunctival haemorrhage	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Conjunctival hyperaemia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Diplopia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Eye discharge	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Eye disorder	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Lacrimation increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Eye disorders Nystagmus	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 2/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Gastroenteritis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Mouth ulceration	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Sensitivity of teeth	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Impaired healing	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Irritability	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Mucosal inflammation	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Oedema	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Influenza	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Vaginal infection	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Brain oedema	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Dermatitis contact	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Fracture	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Injury, poisoning and procedural complications Wound	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Activated partial thromboplastin time prolonged	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Blood cholesterol increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Blood creatinine abnormal	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Haematocrit	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Liver function test increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Lymphocyte count	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Lymphocyte count abnormal	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Monocyte percentage increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Neurological examination abnormal	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Investigations Transaminases increased	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Localised oedema	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	5.0% 4/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Central nervous system necrosis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Eyelid ptosis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Intention tremor	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Pseudomeningocele	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Restlessness	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Vertigo	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Apathy	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Disturbance in attention	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders Memory impairment	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	10.0% 8/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Renal and urinary disorders Micturition urgency	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Renal and urinary disorders Nocturia	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Reproductive system and breast disorders Scrotal swelling	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Epistaxis	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Non-cardiac chest pain	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Sinusitis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Face oedema	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	2.5% 2/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Laceration	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Skin infection	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Vascular disorders Dizziness	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	11.2% 9/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Vascular disorders Incision site haemorrhage	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Vascular disorders Petechiae	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	1.2% 1/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Endocrine disorders Adrenal insufficiency	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Metabolism and nutrition disorders Anorexia	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Cognitive disturbance	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Fecal incontinence	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
General disorders Fever	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Fecal Urgency	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders GASSY, ABDOMINAL PAIN AND FEELING FLUSHED	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations PIMPLE LIKE SORE	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Infections and infestations Shingles	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Lip pain	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Gastrointestinal disorders Mucositis oral	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Nervous system disorders Neuralgia	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Renal and urinary disorders Proteinuria	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Psychiatric disorders EMOTIONAL LABILITY	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Skin and subcutaneous tissue disorders Rash acnneiform	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	16.7% 1/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Cold	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Dry sinuses	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	33.3% 1/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Flu like symptoms	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Head cold	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years
Respiratory, thoracic and mediastinal disorders Sore throat	25.0% 1/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/3 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/6 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/4 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years	0.00% 0/80 • Patients were assessed for adverse events relating to investigational treatment for 12 weeks, patients were monitored for vital status for up to 5 years

Additional Information

Sara Penchev

BioMimetix JV, LLC

Phone: 610-308-6640

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place