Trial Outcomes & Findings for Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer. (NCT NCT02335944)

Last Updated: 2023-06-18

Results Overview

Number of participants with DLTs in the Phase Ib part. A DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with EGF816 in combination with INC280 during the escalation part of the study (Phase Ib)

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

177 participants

Primary outcome timeframe

Up to first 28 days of treatment

Results posted on

2023-06-18

Participant Flow

Participants took part in 19 investigative sites in 11 countries. Due to early study termination, Group 5 (Phase II part) was never opened

The screening period began once patients had signed the study informed consent. All screening/baseline evaluations were performed ≤ 28 days before Cycle 1 Day 1.

Participant milestones

Participant milestones
Measure	Phase IB Part- INC280 200mg BID/ EGF816 50mg QD Combination of INC280 200mg twice daily (BID) and EGF816 50mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.
Treatment Phase STARTED	4	5	3	16	5	52	3	47	42
Treatment Phase COMPLETED	0	0	0	1	0	2	0	5	6
Treatment Phase NOT COMPLETED	4	5	3	15	5	50	3	42	36
Post-treatment Follow-up STARTED	1	0	0	2	0	13	0	5	3
Post-treatment Follow-up COMPLETED	0	0	0	0	0	0	0	0	0
Post-treatment Follow-up NOT COMPLETED	1	0	0	2	0	13	0	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase IB Part- INC280 200mg BID/ EGF816 50mg QD Combination of INC280 200mg twice daily (BID) and EGF816 50mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.
Treatment Phase Progressive Disease	2	5	2	11	4	25	2	30	27
Treatment Phase Adverse Event	2	0	0	2	1	15	0	5	7
Treatment Phase Physician Decision	0	0	0	1	0	6	1	2	1
Treatment Phase Study Terminated By Sponsor	0	0	0	1	0	3	0	1	1
Treatment Phase Subject/Guardian Decision	0	0	1	0	0	1	0	4	0
Post-treatment Follow-up Progressive Disease	0	0	0	1	0	9	0	2	3
Post-treatment Follow-up Subject/Guardian Decision	0	0	0	0	0	2	0	0	0
Post-treatment Follow-up Terminated by Sponsor	0	0	0	0	0	0	0	2	0
Post-treatment Follow-up Adverse Event	0	0	0	0	0	1	0	0	0
Post-treatment Follow-up Death	0	0	0	1	0	1	0	0	0
Post-treatment Follow-up Physician Decision	1	0	0	0	0	0	0	1	0

Baseline Characteristics

Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase IB Part- INC280 200mg BID/ EGF816 50mg QD n=4 Participants Combination of INC280 200mg twice daily (BID) and EGF816 50mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=16 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=5 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) n=52 Participants NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) n=3 Participants NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=47 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) n=42 Participants NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)	Total n=177 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants	3 Participants n=21 Participants	33 Participants n=10 Participants	1 Participants n=115 Participants	30 Participants n=24 Participants	24 Participants n=42 Participants	0 Participants n=42 Participants	112 Participants n=42 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	19 Participants n=10 Participants	2 Participants n=115 Participants	17 Participants n=24 Participants	18 Participants n=42 Participants	0 Participants n=42 Participants	65 Participants n=42 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants	4 Participants n=21 Participants	38 Participants n=10 Participants	2 Participants n=115 Participants	33 Participants n=24 Participants	24 Participants n=42 Participants	0 Participants n=42 Participants	118 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	1 Participants n=21 Participants	14 Participants n=10 Participants	1 Participants n=115 Participants	14 Participants n=24 Participants	18 Participants n=42 Participants	0 Participants n=42 Participants	59 Participants n=42 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants	4 Participants n=21 Participants	26 Participants n=10 Participants	2 Participants n=115 Participants	30 Participants n=24 Participants	20 Participants n=42 Participants	0 Participants n=42 Participants	98 Participants n=42 Participants
Race/Ethnicity, Customized Caucasian	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	22 Participants n=10 Participants	1 Participants n=115 Participants	16 Participants n=24 Participants	21 Participants n=42 Participants	0 Participants n=42 Participants	70 Participants n=42 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	8 Participants n=42 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to first 28 days of treatment

Population: All participants in Phase Ib part who received at least one dose of INC280 or EGF816, and who either completed a minimum exposure requirement or who had a DLT during the first 28 days of treatment (Cycle 1)

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=1 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=13 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=5 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 4 years

Population: All participants in Group 1, 2 or 3 (Phase II part) who received at least one dose of either INC280 or EGF816

ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) determined by investigator's assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). ORR was assessed in Group 1, 2 and 3 (Phase II part). CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=3 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=47 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=52 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Group 1, 2 and 3: Overall Response Rate (ORR) by Investigator's Assessment Per RECIST 1.1	33.3 Percentage of participants Interval 0.8 to 90.6	61.7 Percentage of participants Interval 46.4 to 75.5	—	—	28.8 Percentage of participants Interval 17.1 to 43.1	—	—	—	—	—

PRIMARY outcome

Timeframe: From start of treatment up to 30 days after last dose of study treatment, assessed up to 3.7 years

Population: All participants in Group 4 (Phase II part) who received at least one dose of INC280 or EGF816

Number of participants in Group 4 (Phase II part) with AEs and SAEs. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward event resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=42 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Group 4: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) SAEs	—	—	—	—	26 Participants	—	—	—	—	—
Phase II Group 4: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) AEs	—	—	—	—	42 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: From start of treatment until end of treatment, assessed up to 3.6 years

Population: All participants in Group 4 (Phase II part) who received at least one dose of INC280 or EGF816

Number of participants with at least one dose reduction of INC280, at least one dose interruption of INC280, at least one dose reduction of EGF816 and at least one dose interruption of EGF816 in the Group 4 (Phase II part).

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=42 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Group 4: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618 Dose Reduction of INC280	—	—	—	—	30 Participants	—	—	—	—	—
Phase II Group 4: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618 Dose Interruption of INC280	—	—	—	—	31 Participants	—	—	—	—	—
Phase II Group 4: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618 Dose Reduction of EGF816	—	—	—	—	12 Participants	—	—	—	—	—
Phase II Group 4: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618 Dose Interruption of EGF816	—	—	—	—	35 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: From start of treatment until end of treatment, assessed up to 3.6 years

Population: All participants in Group 4 (Phase II part) who received at least one dose of INC280 or EGF816

Dose intensity, defined as the ratio of total dose received and actual duration, for participants in Group 4 (Phase II part)

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=42 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Group 4: Dose Intensity INC280	—	—	—	—	666.2 milligram/day Standard Deviation 148.97	—	—	—	—	—
Phase II Group 4: Dose Intensity EGF816	—	—	—	—	87.4 milligram/day Standard Deviation 14.82	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 3 years (while on INC280 monotherapy)

Population: Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)

ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) determined by Investigator assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for participants in Group 5 (Phase II part) while on treatment with INC280 monotherapy. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment until end of treatment, assessed up to approximately 5 years

Population: All participants in Phase Ib part who received at least one dose of INC280 or EGF816

Number of participants in Phase Ib with at least one dose reduction of INC280, at least one dose interruption of INC280, at least one dose reduction of EGF816 and at least one dose interruption of EGF816 .

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=16 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=5 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618 Dose Reduction of INC280	4 Participants	2 Participants	10 Participants	5 Participants	2 Participants	—	—	—	—	—
Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618 Dose Interruption of INC280	2 Participants	2 Participants	12 Participants	5 Participants	2 Participants	—	—	—	—	—
Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618 Dose Reduction of EGF816	1 Participants	1 Participants	5 Participants	3 Participants	2 Participants	—	—	—	—	—
Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618 Dose Interruption of EGF816	2 Participants	2 Participants	11 Participants	5 Participants	2 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From start of treatment until end of treatment, assessed up to approximately 4 years

Population: All participants in Group 1, 2 and 3 (Phase II part) who received at least one dose of INC280 or EGF816

Number of participants in Groups 1, 2 and 3 (Phase II part) with at least one dose reduction of INC280, at least one dose interruption of INC280, at least one dose reduction of EGF816 and at least one dose interruption of EGF816 .

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=3 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=47 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=52 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Group 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618 Dose Reduction of INC280	3 Participants	34 Participants	—	—	33 Participants	—	—	—	—	—
Phase II Group 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618 Dose Interruption of INC280	3 Participants	39 Participants	—	—	31 Participants	—	—	—	—	—
Phase II Group 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618 Dose Reduction of EGF816	2 Participants	23 Participants	—	—	17 Participants	—	—	—	—	—
Phase II Group 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618 Dose Interruption of EGF816	3 Participants	40 Participants	—	—	34 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From start of treatment until end of treatment, assessed up to approximately 5 years

Population: All participants in Phase Ib part who received at least one dose of INC280 or EGF816

Dose intensity, defined as the ratio of total dose received and actual duration, in Phase Ib participants

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=16 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=5 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Dose Intensity INC280	356.9 milligram/day Standard Deviation 71.14	596.3 milligram/day Standard Deviation 200.24	658.2 milligram/day Standard Deviation 158.18	463.4 milligram/day Standard Deviation 212.52	319.1 milligram/day Standard Deviation 101.09	—	—	—	—	—
Phase Ib: Dose Intensity EGF816	89.6 milligram/day Standard Deviation 17.93	60.0 milligram/day Standard Deviation 13.36	85.2 milligram/day Standard Deviation 17.28	97.7 milligram/day Standard Deviation 36.43	40.0 milligram/day Standard Deviation 12.60	—	—	—	—	—

SECONDARY outcome

Timeframe: From start of treatment until end of treatment, assessed up to approximately 4 years

Population: All participants in Group 1, 2 and 3 (Phase II part) who received at least one dose of INC280 or EGF816

Dose intensity, defined as the ratio of total dose received and actual duration, in Group 1, 2 and 3 (Phase II)

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=3 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=47 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=52 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Group 1, 2 and 3: Dose Intensity INC280	562.9 milligram/day Standard Deviation 38.36	634.7 milligram/day Standard Deviation 172.33	—	—	662.9 milligram/day Standard Deviation 160.73	—	—	—	—	—
Phase II Group 1, 2 and 3: Dose Intensity EGF816	76.3 milligram/day Standard Deviation 15.31	84.8 milligram/day Standard Deviation 15.53	—	—	85.2 milligram/day Standard Deviation 18.21	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 5 years

Population: All participants in Phase Ib part who received at least one dose of INC280 or EGF816

ORR is defined as percentage of participants with best overall response of PR+CR determined by Investigator's assessment in accordance to RECIST 1.1. ORR was assessed in Phase Ib participants. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=16 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=5 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Overall Response Rate (ORR) Per RECIST 1.1 Based on Investigator's Assessment	40.0 Percentage of participants Interval 5.3 to 85.3	33.3 Percentage of participants Interval 0.8 to 90.6	50.0 Percentage of participants Interval 24.7 to 75.3	60.0 Percentage of participants Interval 14.7 to 94.7	0 Percentage of participants Interval 0.0 to 60.2	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 4 years

Population: All participants in Group 4 (Phase II part) who received at least one dose of INC280 or EGF816

ORR is defined as percentage of participants with best overall response of PR+CR determined by Investigator's assessment in accordance to RECIST 1.1. ORR was assessed in Group 4 (Phase II) CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=42 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Group 4: Overall Response Rate (ORR) Per RECIST 1.1 Based on Investigator's Assessment	—	—	—	—	42.9 Percentage of participants Interval 27.7 to 59.0	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of first dose to first documented disease progression or death, assessed up to approximately 5 years

Population: All participants in Phase Ib part who received at least one dose of INC280 or EGF816

PFS is defined as time from date of first dose of study treatment to date of first documented disease progression determined by Investigator assessment in accordance to RECIST 1.1.or death due to any cause. The PFS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, PFS is censored at the date of last adequate tumor assessment. PFS was assessed in Phase Ib participants

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=16 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=5 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Progression Free Survival (PFS) Per RECIST 1.1 Based on Investigator's Assessment	7.4 Months Interval 1.6 to NA: Not estimable due to insufficient number of participants with events.	3.5 Months Interval 0.8 to NA: Not estimable due to insufficient number of participants with events.	5.7 Months Interval 1.9 to 42.1	14.5 Months Interval 7.3 to NA: Not estimable due to insufficient number of participants with events.	5.6 Months Interval 3.5 to NA: Not estimable due to insufficient number of participants with events.	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of first dose to first documented disease progression or death, assessed up to approximately 4 years

Population: All participants in Group 1, 2 ,3 and 4 (Phase II part) who received at least one dose of INC280 or EGF816

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=3 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=47 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=42 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=52 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Groups 1, 2, 3 and 4: Progression Free Survival (PFS) Per RECIST 1.1 Based on Investigator's Assessment	3.8 Months Interval 3.7 to NA: Not estimable due to insufficient number of participants with events.	10.1 Months Interval 7.6 to 13.8	10.9 Months Interval 5.6 to 19.2	—	5.6 Months Interval 3.7 to 7.4	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of the first dose to the date of first documented response, up to approximately 5 years

Population: All participants in Phase Ib part who received at least one dose of INC280 or EGF816

TTR is defined as the time from the date of the first dose to the date of first documented response (CR or PR) determined by Investigator assessment in accordance to RECIST 1.1. The TTR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, duration was censored at the date of last adequate tumor assessment. TTR was assessed in Phase Ib participants. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=16 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=5 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Time to Response (TTR) Per RECIST 1.1 Based on Investigator's Assessment	NA Months Interval 1.8 to NA: Not estimable due to insufficient number of participants with events.	NA Months Interval 1.7 to NA: Not estimable due to insufficient number of participants with events.	3.5 Months Interval 1.6 to NA: Not estimable due to insufficient number of participants with events.	4.5 Months Interval 1.9 to NA: Not estimable due to insufficient number of participants with events.	NA Months NA: Not estimable due to insufficient number of participants with events.	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of the first dose to the date of first documented response, up to approximately 4 years

Population: All participants in Group 1, 2 ,3 and 4 (Phase II part) who received at least one dose of INC280 or EGF816

TTR is defined as the time from the date of the first dose to the date of first documented response (CR or PR) determined by Investigator assessment in accordance to RECIST 1.1. The TTR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, duration was censored at the date of last adequate tumor assessment. TTR was assessed in Group 1, 2, 3 and 4 (Phase II) CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=3 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=47 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=42 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=52 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Groups 1, 2, 3 and 4: Time to Response (TTR) Per RECIST 1.1 Based on Investigator's Assessment	NA Months Interval 1.8 to NA: Not estimable due to insufficient number of participants with events.	1.9 Months Interval 1.8 to 5.9	NA Months Interval 3.6 to NA: Not estimable due to insufficient number of participants with events.	—	NA Months Interval 5.4 to NA: Not estimable due to insufficient number of participants with events.	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of first documented response to first documented disease progression or death, assessed up to approximately 5 years

Population: All participants in Phase Ib part who received at least one dose of INC280 or EGF816 and had a documented response (CR or PR)

DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression determined by Investigator assessment in accordance to RECIST 1.1 or death due to underlying cancer. The DOR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, duration was censored at the date of last adequate tumor assessment. DOR was assessed in Phase Ib participants CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=2 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=1 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=8 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Duration of Response (DOR) Per RECIST 1.1 Based on Investigator's Assessment	8.8 Months Interval 5.6 to NA: Not estimable due to insufficient number of participants with events.	14.8 Months NA: Not estimable due to insufficient number of participants with events.	25.3 Months Interval 3.6 to 47.9	8.0 Months Interval 5.4 to NA: Not estimable due to insufficient number of participants with events.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of first documented response to first documented disease progression or deaths, assessed up to approximately 4 years

Population: All participants in Group 1, 2 ,3 and 4 (Phase II part) who received at least one dose of INC280 or EGF816 and had a documented response (CR or PR)

DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression determined by Investigator assessment in accordance to RECIST 1.1 or death due to underlying cancer. The DOR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, duration was censored at the date of last adequate tumor assessment. DOR was assessed in Group 1, 2, 3 and 4 (Phase II) CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=1 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=29 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=18 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=15 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Groups 1, 2, 3 and 4: Duration of Response (DOR) Per RECIST 1.1 Based on Investigator's Assessment	12.0 Months NA: Not estimable due to insufficient number of participants with events.	11.6 Months Interval 6.6 to 17.5	14.5 Months Interval 9.2 to NA: Not estimable due to insufficient number of participants with events.	—	6.5 Months Interval 3.7 to 10.8	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 5 years

Population: All participants in Phase Ib part who received at least one dose of INC280 or EGF816

DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease (SD) determined by Investigator assessment in accordance to RECIST 1.1. DCR was assessed in Phase Ib participants CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=16 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=5 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Disease Control Rate (DCR) Per RECIST 1.1 Based on Investigator's Assessment	60.0 Percentage of participants Interval 14.7 to 94.7	33.3 Percentage of participants Interval 0.8 to 90.6	62.5 Percentage of participants Interval 35.4 to 84.8	80.0 Percentage of participants Interval 28.4 to 99.5	100 Percentage of participants Interval 39.8 to 100.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 4 years

Population: All participants in Group 1, 2 ,3 and 4 (Phase II part) who received at least one dose of INC280 or EGF816

DCR is defined as the percentage of participants with best overall response of CR, PR, or SD determined by Investigator assessment in accordance to RECIST 1.1. DCR was assessed in Group 1, 2, 3 and 4 (Phase II) CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=3 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=47 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=42 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=52 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Group 1, 2 3 and 4: Disease Control Rate (DCR) Per RECIST 1.1 Based on Investigator's Assessment	100 Percentage of participants Interval 29.2 to 100.0	93.6 Percentage of participants Interval 82.5 to 98.7	81.0 Percentage of participants Interval 65.9 to 91.4	—	59.6 Percentage of participants Interval 45.1 to 73.0	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of first dose to death, assessed up to approximately 5 years

Population: All participants in Phase Ib part who received at least one dose of INC280 or EGF816

OS is defined as the time from first dose of the study treatment to the date of death due to any cause. The OS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant was not known to have died, survival was censored at the date of last contact. OS was assessed in Phase Ib participants

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=16 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=5 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Overall Survival (OS)	56.5 Months Interval 6.5 to NA: Not estimable due to insufficient number of participants with events.	7.0 Months Interval 1.1 to NA: Not estimable due to insufficient number of participants with events.	17.2 Months Interval 5.7 to 58.7	31.5 Months Interval 16.6 to NA: Not estimable due to insufficient number of participants with events.	10.1 Months Interval 8.1 to NA: Not estimable due to insufficient number of participants with events.	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of first dose to death, assessed up to approximately 4 years

Population: All participants in Group 1, 2 ,3 and 4 (Phase II part) who received at least one dose of INC280 or EGF816

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=3 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=47 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=42 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=52 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Groups 1, 2, 3 and 4: Overall Survival (OS)	5.6 Months Interval 3.7 to NA: Not estimable due to insufficient number of participants with events.	25.6 Months Interval 18.8 to 33.0	28.9 Months Interval 20.5 to NA: Not estimable due to insufficient number of participants with events.	—	18.8 Months Interval 14.9 to 26.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)

Population: All participants in Phase Ib part who provided at least one evaluable PK concentration and at least one evaluable PK profile for INC280.

Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=1 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=12 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12) of INC280 Cycle 1 Day 1	10500 hoursnanogram/mililiter (hrng/mL) Standard Deviation 4320	38300 hoursnanogram/mililiter (hrng/mL)	22200 hoursnanogram/mililiter (hrng/mL) Standard Deviation 10700	23000 hoursnanogram/mililiter (hrng/mL) Standard Deviation 11600	12300 hoursnanogram/mililiter (hrng/mL) Standard Deviation 4710	—	—	—	—	—
Phase Ib: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12) of INC280 Cycle 1 Day 15	11800 hoursnanogram/mililiter (hrng/mL) Standard Deviation 3360	48800 hoursnanogram/mililiter (hrng/mL)	28900 hoursnanogram/mililiter (hrng/mL) Standard Deviation 12700	23000 hoursnanogram/mililiter (hrng/mL) Standard Deviation 3440	11600 hoursnanogram/mililiter (hrng/mL) Standard Deviation 3400	—	—	—	—	—
Phase Ib: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12) of INC280 Cycle 2 Day 1	11100 hoursnanogram/mililiter (hrng/mL) Standard Deviation 1770	—	21600 hoursnanogram/mililiter (hrng/mL) Standard Deviation 7370	24900 hoursnanogram/mililiter (hrng/mL) Standard Deviation 5190	11300 hoursnanogram/mililiter (hrng/mL) Standard Deviation 4050	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)

Population: All participants in Phase Ib part who provided at least one evaluable PK concentration and at least one evaluable PK profile for INC280.

Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=1 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=12 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Peak Plasma Concentration (Cmax) of INC280 Cycle 1 Day 1	2530 nanogram/mililiter (ng/mL) Standard Deviation 1080	8000 nanogram/mililiter (ng/mL)	5100 nanogram/mililiter (ng/mL) Standard Deviation 2550	5930 nanogram/mililiter (ng/mL) Standard Deviation 1330	3630 nanogram/mililiter (ng/mL) Standard Deviation 588	—	—	—	—	—
Phase Ib: Peak Plasma Concentration (Cmax) of INC280 Cycle 1 Day 15	2840 nanogram/mililiter (ng/mL) Standard Deviation 1350	12000 nanogram/mililiter (ng/mL)	5780 nanogram/mililiter (ng/mL) Standard Deviation 2640	4350 nanogram/mililiter (ng/mL) Standard Deviation 933	3070 nanogram/mililiter (ng/mL) Standard Deviation 1120	—	—	—	—	—
Phase Ib: Peak Plasma Concentration (Cmax) of INC280 Cycle 2 Day 1	2800 nanogram/mililiter (ng/mL) Standard Deviation 797	—	4830 nanogram/mililiter (ng/mL) Standard Deviation 1390	6370 nanogram/mililiter (ng/mL) Standard Deviation 1060	3590 nanogram/mililiter (ng/mL) Standard Deviation 1620	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)

Population: All participants in Phase Ib part who provided at least one evaluable PK concentration and at least one evaluable PK profile for INC280.

Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment)

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=1 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=12 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Time to Reach Maximum Concentration (Tmax) of INC280 Cycle 1 Day 1	2.00 Hours Interval 1.0 to 4.0	2.00 Hours Interval 2.0 to 2.0	2.01 Hours Interval 1.0 to 7.67	2.00 Hours Interval 1.02 to 2.13	1.07 Hours Interval 1.0 to 2.0	—	—	—	—	—
Phase Ib: Time to Reach Maximum Concentration (Tmax) of INC280 Cycle 1 Day 15	2.00 Hours Interval 0.883 to 7.98	1.17 Hours Interval 1.17 to 1.17	1.97 Hours Interval 0.95 to 4.0	1.50 Hours Interval 1.0 to 2.0	1.12 Hours Interval 1.03 to 2.05	—	—	—	—	—
Phase Ib: Time to Reach Maximum Concentration (Tmax) of INC280 Cycle 2 Day 1	2.00 Hours Interval 1.0 to 3.83	—	1.94 Hours Interval 0.983 to 4.0	1.51 Hours Interval 1.02 to 2.0	1.00 Hours Interval 1.0 to 2.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)

Population: All participants in Group 3 and 4 (Phase II part) who provided at least one evaluable PK concentration and at least one evaluable PK profile for INC280

Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=15 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=9 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Groups 3 and 4: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12) of INC280 Cycle 1 Day 1	16900 hoursnanogram/mililiter (hrng/mL) Standard Deviation 7360	—	—	—	22000 hoursnanogram/mililiter (hrng/mL) Standard Deviation 8000	—	—	—	—	—
Phase II Groups 3 and 4: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12) of INC280 Cycle 2 Day 1	20500 hoursnanogram/mililiter (hrng/mL) Standard Deviation 7440	—	—	—	19700 hoursnanogram/mililiter (hrng/mL) Standard Deviation 11200	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)

Population: All participants in Group 3 and 4 (Phase II part) who provided at least one evaluable PK concentration and at least one evaluable PK profile for INC280

Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=15 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=9 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Groups 3 and 4: Peak Plasma Concentration (Cmax) of INC280 Cycle 1 Day 1	3420 nanogram/mililiter (ng/mL) Standard Deviation 1550	—	—	—	4770 nanogram/mililiter (ng/mL) Standard Deviation 1460	—	—	—	—	—
Phase II Groups 3 and 4: Peak Plasma Concentration (Cmax) of INC280 Cycle 2 Day 1	3940 nanogram/mililiter (ng/mL) Standard Deviation 1660	—	—	—	4360 nanogram/mililiter (ng/mL) Standard Deviation 2060	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)

Population: All participants in Group 3 and 4 (Phase II part) who provided at least one evaluable PK concentration and at least one evaluable PK profile for INC280

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=15 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=9 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Groups 3 and 4: Time to Reach Maximum Concentration (Tmax) of INC280 Cycle 1 Day 1	2.08 Hours Interval 1.85 to 8.0	—	—	—	1.99 Hours Interval 1.0 to 4.0	—	—	—	—	—
Phase II Groups 3 and 4: Time to Reach Maximum Concentration (Tmax) of INC280 Cycle 2 Day 1	3.82 Hours Interval 1.0 to 4.1	—	—	—	1.47 Hours Interval 1.0 to 7.08	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)

Population: All participants in Phase Ib part who provided at least one evaluable PK concentration and at least one evaluable PK profile for EGF816.

Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=13 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of EGF816 Cycle 1 Day 1	5850 hoursnanogram/mililiter (hrng/mL) Standard Deviation 4380	4010 hoursnanogram/mililiter (hrng/mL) Standard Deviation 534	5930 hoursnanogram/mililiter (hrng/mL) Standard Deviation 3600	10500 hoursnanogram/mililiter (hrng/mL) Standard Deviation 3400	3920 hoursnanogram/mililiter (hrng/mL) Standard Deviation 1450	—	—	—	—	—
Phase Ib: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of EGF816 Cycle 1 Day 15	9630 hoursnanogram/mililiter (hrng/mL) Standard Deviation 4060	7330 hoursnanogram/mililiter (hrng/mL) Standard Deviation 108	11100 hoursnanogram/mililiter (hrng/mL) Standard Deviation 5340	16400 hoursnanogram/mililiter (hrng/mL) Standard Deviation 5670	5200 hoursnanogram/mililiter (hrng/mL) Standard Deviation 2010	—	—	—	—	—
Phase Ib: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of EGF816 Cycle 2 Day 1	7460 hoursnanogram/mililiter (hrng/mL) Standard Deviation 2340	—	10500 hoursnanogram/mililiter (hrng/mL) Standard Deviation 7480	11400 hoursnanogram/mililiter (hrng/mL) Standard Deviation 2360	4080 hoursnanogram/mililiter (hrng/mL) Standard Deviation 1130	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)

Population: All participants in Phase Ib part who provided at least one evaluable PK concentration and at least one evaluable PK profile for EGF816.

Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=13 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Peak Plasma Concentration (Cmax) of EGF816 Cycle 1 Day 1	465 nanogram/mililiter (ng/mL) Standard Deviation 323	302 nanogram/mililiter (ng/mL) Standard Deviation 8.49	381 nanogram/mililiter (ng/mL) Standard Deviation 231	777 nanogram/mililiter (ng/mL) Standard Deviation 281	258 nanogram/mililiter (ng/mL) Standard Deviation 104	—	—	—	—	—
Phase Ib: Peak Plasma Concentration (Cmax) of EGF816 Cycle 1 Day 15	677 nanogram/mililiter (ng/mL) Standard Deviation 321	517 nanogram/mililiter (ng/mL) Standard Deviation 180	595 nanogram/mililiter (ng/mL) Standard Deviation 261	1010 nanogram/mililiter (ng/mL) Standard Deviation 354	361 nanogram/mililiter (ng/mL) Standard Deviation 165	—	—	—	—	—
Phase Ib: Peak Plasma Concentration (Cmax) of EGF816 Cycle 2 Day 1	583 nanogram/mililiter (ng/mL) Standard Deviation 261	—	604 nanogram/mililiter (ng/mL) Standard Deviation 365	814 nanogram/mililiter (ng/mL) Standard Deviation 137	269 nanogram/mililiter (ng/mL) Standard Deviation 90.8	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)

Population: All participants in Phase Ib part who provided at least one evaluable PK concentration and at least one evaluable PK profile for EGF816.

Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment)

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=13 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase Ib: Time to Reach Maximum Concentration (Tmax) of EGF816 Cycle 1 Day 1	3.90 Hours (hr) Interval 2.0 to 4.0	3.00 Hours (hr) Interval 2.0 to 4.0	4.00 Hours (hr) Interval 2.0 to 8.99	4.00 Hours (hr) Interval 2.03 to 4.02	3.03 Hours (hr) Interval 1.08 to 4.02	—	—	—	—	—
Phase Ib: Time to Reach Maximum Concentration (Tmax) of EGF816 Cycle 1 Day 15	3.95 Hours (hr) Interval 2.0 to 4.0	4.00 Hours (hr) Interval 2.17 to 4.05	5.90 Hours (hr) Interval 2.17 to 11.9	3.93 Hours (hr) Interval 3.83 to 4.02	2.07 Hours (hr) Interval 2.0 to 4.05	—	—	—	—	—
Phase Ib: Time to Reach Maximum Concentration (Tmax) of EGF816 Cycle 2 Day 1	4.00 Hours (hr) Interval 2.0 to 4.0	—	4.00 Hours (hr) Interval 1.98 to 7.0	3.05 Hours (hr) Interval 2.1 to 4.0	4.00 Hours (hr) Interval 3.95 to 4.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)

Population: All participants in Group 3 and 4 (Phase II part) who provided at least one evaluable PK concentration and at least one evaluable PK profile for EGF816.

Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=15 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=7 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Groups 3 and 4: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of EGF816 Cycle 1 Day 1	3420 hoursnanogram/mililiter (hrng/mL) Standard Deviation 1700	—	—	—	6390 hoursnanogram/mililiter (hrng/mL) Standard Deviation 2460	—	—	—	—	—
Phase II Groups 3 and 4: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of EGF816 Cycle 2 Day 1	7670 hoursnanogram/mililiter (hrng/mL) Standard Deviation 3330	—	—	—	11100 hoursnanogram/mililiter (hrng/mL) Standard Deviation 2000	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)

Population: All participants in Group 3 and 4 (Phase II part) who provided at least one evaluable PK concentration and at least one evaluable PK profile for EGF816.

Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=15 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=7 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Groups 3 and 4: Peak Plasma Concentration (Cmax) of EGF816 Cycle 1 Day 1	239 nanogram/mililiter (ng/mL) Standard Deviation 107	—	—	—	448 nanogram/mililiter (ng/mL) Standard Deviation 184	—	—	—	—	—
Phase II Groups 3 and 4: Peak Plasma Concentration (Cmax) of EGF816 Cycle 2 Day 1	447 nanogram/mililiter (ng/mL) Standard Deviation 175	—	—	—	658 nanogram/mililiter (ng/mL) Standard Deviation 117	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)

Population: All participants in Group 3 and 4 (Phase II part) who provided at least one evaluable PK concentration and at least one evaluable PK profile for EGF816.

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=15 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=7 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
Phase II Groups 3 and 4: Time to Reach Maximum Concentration (Tmax) of EGF816 Cycle 1 Day 1	4.00 Hours (hr) Interval 1.85 to 8.0	—	—	—	4.00 Hours (hr) Interval 1.12 to 8.0	—	—	—	—	—
Phase II Groups 3 and 4: Time to Reach Maximum Concentration (Tmax) of EGF816 Cycle 2 Day 1	4.00 Hours (hr) Interval 3.82 to 8.0	—	—	—	4.00 Hours (hr) Interval 2.0 to 4.13	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of first documented response to the date of first documented disease progression or death, assessed up to approximately 3 years (while on INC280 monotherapy)

Population: Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)

DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1 for participants in Group 5 (Phase II) while on INC280 monotherapy treatment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 3 years (while on INC280 monotherapy)

Population: Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)

DCR is defined as the percentage of participants with best overall response of CR, PR, or SD determined by Investigator assessment in accordance to RECIST 1.1 for participants in Group 5 (Phase II) while on INC280 monotherapy treatment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 3 years (while on INC280 monotherapy)

Population: Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)

PFS is defined as time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1 for participants in Group 5 (Phase II) while on INC280 monotherapy treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment until end of treatment, up to approximately 3 years

Population: Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)

Number of participants with dose modifications for INC280 monotherapy as well as INC280 in combination with EGF816 therapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment until end of treatment, up to approximately 3 years

Population: Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)

Dose intensity is defined as the ratio of total dose received and actual duration for INC280 monotherapy as well as INC280 in combination with EGF816 therapy in Group 5 (Phase II)

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: On-treatment: up to approximately 5 years (Phase Ib) and 4 years (Phase II). Post-treatment survival follow-up: Up to approximately 5 years (Phase Ib) and 4 years (Phase II).

Population: All participants in Phase Ib part and Group 1, 2, 3 and 4 (Phase II part) who received at least one dose of INC280 or EGF816. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)

On-treatment deaths were collected from first dose of study medication to 30 days after the last dose of study medication. Post-treatment survival follow-up deaths were collected after 30 days post-treatment. All deaths refer to the sum of on-treatment and post-treatment deaths

Outcome measures

Outcome measures
Measure	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD n=5 Participants Combination of INC280 200mg twice daily (BID) and EGF816 100mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD n=3 Participants Combination of INC280 400mg twice daily (BID) and EGF816 75mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD n=16 Participants Combination of INC280 400mg twice daily (BID) and EGF816 100mg once daily (QD) in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD n=5 Participants Combination of INC280 400mg twice daily (BID) and EGF816 150mg once daily (QD) in fasted state in NSCLC participants with previously documented EGFR mutation, who progressed on EGFR TKI treatment	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=4 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 1 (EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant) n=52 Participants NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received 1 to 3 lines of systemic antineoplastic therapy prior to study entry including one line maximum of 1st or 2nd generation EGFR TKI. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 2 (EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve) n=3 Participants NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who received none to 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 3 (EGFRmut, T790M Negative, Any MET, 1L Antineoplastic) n=47 Participants NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic therapy. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fasted state	Phase II- Group 4 (EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic) n=42 Participants NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who received none to 2 prior lines of systemic antineoplastic therapy prior to study entry. Participants were treated with 400 mg twice daily for INC280 and 100 mg once daily for EGF816 in fed state.	Phase II- Group 5 (EGFRmut, T790M-, MET GCN≥5, 2L Antineoplastic, EGFR TKI Resistant) NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants started with 400 mg twice daily for INC280 (monotherapy) (fasted or food state) and then had the opportunity to continue with the combination of 400 mg twice daily for INC280 and 100 mg once daily for EGF816 (fasted or food state)
All Collected Deaths Post-treatment survival follow-up deaths	3 Participants	2 Participants	9 Participants	3 Participants	4 Participants	26 Participants	1 Participants	25 Participants	22 Participants	—
All Collected Deaths On-treatment deaths	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	9 Participants	2 Participants	5 Participants	1 Participants	—
All Collected Deaths All deaths	3 Participants	3 Participants	11 Participants	3 Participants	4 Participants	35 Participants	3 Participants	30 Participants	23 Participants	—

Adverse Events

Phase IB Part- INC280 200mg BID/ EGF816 50mg QD (On-treatment)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase IB Part- INC280 200mg BID/ EGF816 50mg QD (Post-treatment FU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Phase IB Part- INC280 200mg BID/ EGF816 100mg QD (On-treatment)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Phase IB Part- INC280 200mg BID/ EGF816 100mg QD (Post-treatment FU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Phase IB Part- INC280 400mg BID/ EGF816 75mg QD (On-treatment)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase IB Part- INC280 400mg BID/ EGF816 75mg QD (Post-treatment FU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Phase IB Part- INC280 400mg BID/ EGF816 100mg QD (On-treatment)

Serious events: 11 serious events

Other events: 16 other events

Deaths: 2 deaths

Phase IB Part- INC280 400mg BID/ EGF816 100mg QD (Post-treatment FU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Phase IB Part- INC280 400mg BID/ EGF816 150mg QD (On-treatment)

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Phase IB Part- INC280 400mg BID/ EGF816 150mg QD (Post-treatment FU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Phase II- EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant (On-treatment)

Serious events: 29 serious events

Other events: 51 other events

Deaths: 9 deaths

Phase II- EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant (Post-treatment FU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 26 deaths

Phase II- EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve (On-treatment)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Phase II-EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve (Post-treatment FU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Phase II- EGFRmut, T790M Negative, Any MET, 1L Antineoplastic (On-treatment)

Serious events: 33 serious events

Other events: 47 other events

Deaths: 5 deaths

Phase II- EGFRmut, T790M Negative, Any MET, 1L Antineoplastic (Post-treatment FU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 25 deaths

Phase II-EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic (On-treatment)

Serious events: 26 serious events

Other events: 42 other events

Deaths: 1 deaths

Phase II-EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic (Post-treatment FU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 22 deaths

Serious adverse events

Serious adverse events
Measure	Phase IB Part- INC280 200mg BID/ EGF816 50mg QD (On-treatment) n=4 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase IB Part- INC280 200mg BID/ EGF816 50mg QD (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD (On-treatment) n=5 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD (On-treatment) n=3 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD (On-treatment) n=16 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD (On-treatment) n=5 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase II- EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant (On-treatment) n=52 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase II- EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase II- EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve (On-treatment) n=3 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase II-EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase II- EGFRmut, T790M Negative, Any MET, 1L Antineoplastic (On-treatment) n=47 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase II- EGFRmut, T790M Negative, Any MET, 1L Antineoplastic (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase II-EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic (On-treatment) n=42 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase II-EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Cardiac disorders Cardiac arrest	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Cardiac disorders Cardio-respiratory arrest	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Cardiac disorders Myocardial ischaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Cardiac disorders Pericardial effusion	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Ear and labyrinth disorders Hypoacusis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Eye disorders Visual impairment	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Ascites	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Colitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Constipation	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Gastric ulcer	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Hiatus hernia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Inguinal hernia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Nausea	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Vomiting	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Asthenia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Fatigue	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders General physical health deterioration	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Influenza like illness	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Non-cardiac chest pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Oedema	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Pyrexia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	8.5% 4/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Hepatobiliary disorders Hepatic failure	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Immune system disorders Anaphylactic shock	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Immune system disorders Hypersensitivity	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Cellulitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Empyema	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Enterocolitis infectious	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Erysipelas	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Herpes zoster	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Herpes zoster meningitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Influenza	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Lower respiratory tract infection	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Meningitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Meningitis aseptic	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Necrotising fasciitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Pleural infection	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Pneumonia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.6% 5/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.5% 4/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Pneumonia aspiration	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Pneumonia chlamydial	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Respiratory tract infection	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Sepsis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Soft tissue infection	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Urinary tract infection	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Urosepsis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Injury, poisoning and procedural complications Procedural pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Alanine aminotransferase increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Amylase increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood bilirubin increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood creatinine increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Ejection fraction decreased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Neutrophil count decreased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Weight decreased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Aphasia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Brain oedema	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Cerebral ischaemia	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Dysarthria	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Epilepsy	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Headache	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Hydrocephalus	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Hypertensive hydrocephalus	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Loss of consciousness	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Neurological decompensation	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Seizure	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Speech disorder	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Spinal cord compression	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Tremor	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Wernicke's encephalopathy	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Psychiatric disorders Apathy	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Psychiatric disorders Confusional state	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Renal and urinary disorders Renal failure	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	5.8% 3/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Hypersensitivity pneumonitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	8.5% 4/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Purpura	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Vascular disorders Embolism	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Vascular disorders Hypertensive crisis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Vascular disorders Hypotension	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)

Other adverse events

Other adverse events
Measure	Phase IB Part- INC280 200mg BID/ EGF816 50mg QD (On-treatment) n=4 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase IB Part- INC280 200mg BID/ EGF816 50mg QD (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD (On-treatment) n=5 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase IB Part- INC280 200mg BID/ EGF816 100mg QD (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD (On-treatment) n=3 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase IB Part- INC280 400mg BID/ EGF816 75mg QD (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD (On-treatment) n=16 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase IB Part- INC280 400mg BID/ EGF816 100mg QD (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD (On-treatment) n=5 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase IB Part- INC280 400mg BID/ EGF816 150mg QD (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase II- EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant (On-treatment) n=52 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase II- EGFRmut, Any T790M, Any MET, 2/4L Antineoplastic, EGFR TKI Resistant (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase II- EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve (On-treatment) n=3 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase II-EGFRmut, de Novo T790M, Any MET, 1/3L Antineoplastic, EGFR TKI naïve (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase II- EGFRmut, T790M Negative, Any MET, 1L Antineoplastic (On-treatment) n=47 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase II- EGFRmut, T790M Negative, Any MET, 1L Antineoplastic (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Phase II-EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic (On-treatment) n=42 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Phase II-EGFRmut, Any T790M, Any MET, 1/3L Antineoplastic (Post-treatment FU) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	66.7% 2/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	17.3% 9/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	23.4% 11/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.5% 4/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	5.8% 3/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Cardiac disorders Angina pectoris	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Cardiac disorders Bradycardia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Ear and labyrinth disorders Deafness	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Ear and labyrinth disorders Deafness transitory	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Ear and labyrinth disorders Ear pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Ear and labyrinth disorders Hypoacusis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Ear and labyrinth disorders Tinnitus	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.8% 6/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Endocrine disorders Hyperthyroidism	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Eye disorders Eye pruritus	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Eye disorders Eye swelling	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Eye disorders Eyelid oedema	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Eye disorders Vision blurred	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Eye disorders Vitreous floaters	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.9% 7/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.5% 4/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	10.6% 5/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Abdominal pain upper	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.8% 6/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	16.7% 7/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Constipation	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	31.2% 5/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.8% 6/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	19.0% 8/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	37.5% 6/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	38.5% 20/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	66.7% 2/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	55.3% 26/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	47.6% 20/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	25.0% 4/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	19.2% 10/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	19.1% 9/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.3% 6/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	18.8% 3/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.3% 6/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Lip blister	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Lip dry	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Mouth ulceration	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	8.5% 4/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.5% 4/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Nausea	50.0% 2/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	66.7% 2/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	68.8% 11/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	100.0% 5/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	53.8% 28/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	100.0% 3/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	57.4% 27/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	45.2% 19/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Odynophagia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	18.8% 3/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.6% 5/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	25.5% 12/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Toothache	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Gastrointestinal disorders Vomiting	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	37.5% 6/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	60.0% 3/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	38.5% 20/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	46.8% 22/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	26.2% 11/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Asthenia	50.0% 2/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	25.0% 4/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	11.5% 6/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	38.3% 18/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	23.8% 10/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Chest pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Chills	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	5.8% 3/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Face oedema	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	18.8% 3/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Fatigue	50.0% 2/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	66.7% 2/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	37.5% 6/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	26.9% 14/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	66.7% 2/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	19.1% 9/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	21.4% 9/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Gait disturbance	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Influenza like illness	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	5.8% 3/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	11.9% 5/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Non-cardiac chest pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	15.4% 8/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.8% 6/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.3% 6/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Oedema peripheral	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	66.7% 2/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	50.0% 8/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	80.0% 4/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	51.9% 27/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	100.0% 3/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	66.0% 31/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	61.9% 26/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	5.8% 3/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Peripheral swelling	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
General disorders Pyrexia	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	43.8% 7/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	60.0% 3/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	15.4% 8/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	23.4% 11/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	28.6% 12/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Immune system disorders Anaphylactoid reaction	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Immune system disorders Hypersensitivity	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Bronchitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Cellulitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	11.9% 5/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Conjunctivitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	5.8% 3/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Cystitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Folliculitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Gastroenteritis	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Herpes zoster	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Infection	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Nasopharyngitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.6% 5/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	10.6% 5/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	11.9% 5/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Paronychia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	31.2% 5/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	5.8% 3/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.9% 7/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	16.7% 7/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Pharyngitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Pneumonia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Respiratory tract infection	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Rhinitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Sinobronchitis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Skin infection	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Tooth infection	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	25.0% 4/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	17.3% 9/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.8% 6/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.3% 6/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Urinary tract infection	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.6% 5/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	8.5% 4/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	19.0% 8/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Infections and infestations Viral infection	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Injury, poisoning and procedural complications Procedural pain	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Alanine aminotransferase increased	50.0% 2/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	13.5% 7/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	66.7% 2/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	27.7% 13/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	31.0% 13/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Amylase increased	50.0% 2/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	50.0% 8/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	21.2% 11/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	23.4% 11/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	16.7% 7/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	66.7% 2/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	27.7% 13/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	26.2% 11/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood albumin decreased	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood alkaline phosphatase increased	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.8% 6/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood bilirubin increased	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood creatine increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood creatine phosphokinase increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	25.0% 4/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.6% 5/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	10.6% 5/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.3% 6/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood creatinine increased	50.0% 2/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	50.0% 8/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	19.2% 10/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	34.0% 16/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	35.7% 15/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood glucose increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood potassium increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood triglycerides increased	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood urea increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Blood uric acid increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations C-reactive protein increased	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Electrocardiogram QT prolonged	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Gamma-glutamyltransferase increased	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	10.6% 5/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	11.9% 5/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Haemoglobin decreased	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Lipase increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	25.0% 4/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	23.1% 12/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.9% 7/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	19.0% 8/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Lymphocyte count decreased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Protein total decreased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Weight decreased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	18.8% 3/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations Weight increased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	5.8% 3/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	8.5% 4/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Investigations White blood cell count decreased	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	62.5% 10/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	26.9% 14/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	29.8% 14/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	21.4% 9/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hyperkalaemia	50.0% 2/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	5.8% 3/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	31.2% 5/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	17.3% 9/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	21.3% 10/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	16.7% 7/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.6% 5/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	8.5% 4/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	18.8% 3/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	18.8% 3/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hypophagia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 2/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	5.8% 3/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	21.3% 10/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.3% 6/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.9% 7/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	19.0% 8/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Flank pain	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	25.5% 12/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 14/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	8.5% 4/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	60.0% 3/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.9% 7/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	16.7% 7/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Amnesia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Dizziness	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	25.0% 4/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	17.3% 9/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	23.4% 11/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	23.8% 10/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Dysaesthesia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Dysgeusia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	8.5% 4/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Epilepsy	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Headache	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	43.8% 7/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	13.5% 7/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	36.2% 17/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	28.6% 12/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Hypoaesthesia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Lethargy	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Neuropathy peripheral	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Post herpetic neuralgia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Seizure	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Nervous system disorders Syncope	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Psychiatric disorders Anxiety	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	8.5% 4/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Psychiatric disorders Confusional state	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Psychiatric disorders Depression	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Psychiatric disorders Insomnia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.5% 4/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Psychiatric disorders Sleep disorder	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Renal and urinary disorders Acute kidney injury	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Renal and urinary disorders Chronic kidney disease	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Renal and urinary disorders Hypertonic bladder	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Renal and urinary disorders Renal failure	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Reproductive system and breast disorders Pelvic pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Reproductive system and breast disorders Perineal pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Reproductive system and breast disorders Prostatomegaly	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	66.7% 2/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	31.2% 5/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	19.2% 10/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	23.4% 11/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 14/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	25.0% 4/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	21.2% 11/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	27.7% 13/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	16.7% 7/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	8.5% 4/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.7% 4/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	11.9% 5/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Pleural effusion	50.0% 2/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	7.1% 3/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	18.8% 3/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	11.9% 5/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Acne	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	8.5% 4/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	3.8% 2/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	21.3% 10/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.5% 4/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	31.2% 5/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	9.6% 5/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.9% 7/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	11.9% 5/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Eczema	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	14.3% 6/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	31.2% 5/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	11.5% 6/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	19.1% 9/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 14/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	13.5% 7/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	23.4% 11/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	21.4% 9/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	18.8% 3/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	80.0% 4/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	19.2% 10/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	29.8% 14/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	21.4% 9/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	12.5% 2/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.4% 3/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.1% 1/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.8% 2/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Vascular disorders Hot flush	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	4.3% 2/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Vascular disorders Hypotension	25.0% 1/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	1.9% 1/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	8.5% 4/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	2.4% 1/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Vascular disorders Pallor	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	33.3% 1/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)
Vascular disorders Thrombosis	0.00% 0/4 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	6.2% 1/16 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/52 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/3 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/47 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	0.00% 0/42 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment, up to approx. 5 years (Phase Ib) and 4 years (Phase II). Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 5 years (Phase Ib) and 4 years (Phase II).These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Due to early termination of the study, no participants were enrolled in Group 5 (Phase II part)

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER