Trial Outcomes & Findings for Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease (NCT NCT00025259)

Last Updated: 2017-04-12

Results Overview

Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1734 participants

Primary outcome timeframe

5 years

Results posted on

2017-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Patients Off-therapy Before Callback-Induction Only) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm II (RER With CR [ABVE-PC, IFRT]) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm III (RER With CR [ABVE-PC]) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm V (RER With PD) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm VI (SER [DECA, ABVE-PC, IFRT]) Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \& G-CSF SC beginning on day 3 \& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cisplatin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Dexamethasone: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Pre	Arm VII (SER [ABVE-PC, IFRT]) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
Overall Study STARTED	52	381	382	571	42	153	153
Overall Study COMPLETED	7	292	301	457	6	101	102
Overall Study NOT COMPLETED	45	89	81	114	36	52	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Patients Off-therapy Before Callback-Induction Only) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm II (RER With CR [ABVE-PC, IFRT]) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm III (RER With CR [ABVE-PC]) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm V (RER With PD) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm VI (SER [DECA, ABVE-PC, IFRT]) Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \& G-CSF SC beginning on day 3 \& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cisplatin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Dexamethasone: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Pre	Arm VII (SER [ABVE-PC, IFRT]) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
Overall Study Death	1	3	0	3	0	1	2
Overall Study Lack of Efficacy	2	46	60	78	11	30	38
Overall Study Lost to Follow-up	2	9	13	13	1	3	1
Overall Study Physician Decision	12	1	0	5	4	2	1
Overall Study Protocol Violation	3	2	2	1	2	1	3
Overall Study Withdrawal by Subject	9	27	6	14	11	8	3
Overall Study Ineligible	14	1	0	0	6	0	1
Overall Study Randomization error	1	0	0	0	1	7	2
Overall Study Adverse Event	1	0	0	0	0	0	0

Baseline Characteristics

Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Patients Off-therapy Before Callback-Induction Only) n=52 Participants Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm II (RER With CR [ABVE-PC, IFRT]) n=381 Participants Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm III (RER With CR [ABVE-PC]) n=382 Participants Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) n=571 Participants Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm V (RER With PD) n=42 Participants Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm VI (SER [DECA, ABVE-PC, IFRT]) n=153 Participants Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \& G-CSF SC beginning on day 3 \& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cisplatin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Dexamethasone: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Pre	Arm VII (SER [ABVE-PC, IFRT]) n=153 Participants Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Total n=1734 Participants Total of all reporting groups
Age, Categorical <=18 years	46 Participants n=5 Participants	363 Participants n=7 Participants	369 Participants n=5 Participants	540 Participants n=4 Participants	40 Participants n=21 Participants	143 Participants n=10 Participants	148 Participants n=115 Participants	1649 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	18 Participants n=7 Participants	13 Participants n=5 Participants	31 Participants n=4 Participants	2 Participants n=21 Participants	10 Participants n=10 Participants	5 Participants n=115 Participants	85 Participants n=24 Participants
Age, Categorical >=65 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
Age, Continuous	16 Years n=5 Participants	14 Years n=7 Participants	14 Years n=5 Participants	15 Years n=4 Participants	15 Years n=21 Participants	15 Years n=10 Participants	15 Years n=115 Participants	15 Years n=24 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	177 Participants n=7 Participants	155 Participants n=5 Participants	288 Participants n=4 Participants	16 Participants n=21 Participants	81 Participants n=10 Participants	77 Participants n=115 Participants	815 Participants n=24 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	204 Participants n=7 Participants	227 Participants n=5 Participants	283 Participants n=4 Participants	26 Participants n=21 Participants	72 Participants n=10 Participants	76 Participants n=115 Participants	919 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	71 Participants n=7 Participants	67 Participants n=5 Participants	74 Participants n=4 Participants	4 Participants n=21 Participants	22 Participants n=10 Participants	14 Participants n=115 Participants	259 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	293 Participants n=7 Participants	306 Participants n=5 Participants	487 Participants n=4 Participants	34 Participants n=21 Participants	127 Participants n=10 Participants	134 Participants n=115 Participants	1425 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	17 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	5 Participants n=115 Participants	50 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	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	0 Participants n=10 Participants	1 Participants n=115 Participants	4 Participants n=24 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	11 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=10 Participants	6 Participants n=115 Participants	50 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	6 Participants n=24 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	45 Participants n=7 Participants	43 Participants n=5 Participants	67 Participants n=4 Participants	6 Participants n=21 Participants	14 Participants n=10 Participants	14 Participants n=115 Participants	194 Participants n=24 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	290 Participants n=7 Participants	297 Participants n=5 Participants	444 Participants n=4 Participants	30 Participants n=21 Participants	122 Participants n=10 Participants	124 Participants n=115 Participants	1348 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	31 Participants n=7 Participants	27 Participants n=5 Participants	45 Participants n=4 Participants	4 Participants n=21 Participants	12 Participants n=10 Participants	8 Participants n=115 Participants	132 Participants n=24 Participants
Region of Enrollment New Zealand	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	0 participants n=115 Participants	4 participants n=24 Participants
Region of Enrollment Canada	8 participants n=5 Participants	30 participants n=7 Participants	45 participants n=5 Participants	51 participants n=4 Participants	1 participants n=21 Participants	20 participants n=10 Participants	20 participants n=115 Participants	175 participants n=24 Participants
Region of Enrollment United States	41 participants n=5 Participants	333 participants n=7 Participants	312 participants n=5 Participants	491 participants n=4 Participants	39 participants n=21 Participants	125 participants n=10 Participants	128 participants n=115 Participants	1469 participants n=24 Participants
Region of Enrollment Israel	0 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	0 participants n=115 Participants	6 participants n=24 Participants
Region of Enrollment Australia	0 participants n=5 Participants	8 participants n=7 Participants	13 participants n=5 Participants	12 participants n=4 Participants	0 participants n=21 Participants	3 participants n=10 Participants	4 participants n=115 Participants	40 participants n=24 Participants
Region of Enrollment Switzerland	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	0 participants n=115 Participants	1 participants n=24 Participants
Region of Enrollment Kuwait	1 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	1 participants n=24 Participants
Region of Enrollment France	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	0 participants n=115 Participants	1 participants n=24 Participants
Region of Enrollment Netherlands	0 participants n=5 Participants	2 participants n=7 Participants	9 participants n=5 Participants	7 participants n=4 Participants	1 participants n=21 Participants	3 participants n=10 Participants	0 participants n=115 Participants	22 participants n=24 Participants
Region of Enrollment Puerto Rico	1 participants n=5 Participants	4 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	1 participants n=115 Participants	13 participants n=24 Participants
Region of Enrollment Bermuda	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	0 participants n=115 Participants	1 participants n=24 Participants
Region of Enrollment French Polynesia	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	0 participants n=10 Participants	0 participants n=115 Participants	1 participants n=24 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

Outcome measures

Outcome measures
Measure	Arm I (Patients Off-therapy Before Callback-Induction Only) n=38 Participants All patients-off therapy before callback-Induction only	Arm II (RER With CR [ABVE-PC, IFRT]) n=380 Participants RER with Complete Response - IFRT (Standard Arm)	Arm III (RER With CR [ABVE-PC]) n=382 Participants RER with Complete Response - no IFRT (Reduced Therapy Arm)	Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) n=571 Participants RER with less than Complete Response - IFRT	Arm V (RER With PD) n=36 Participants RER with Progressive Disease - Off Therapy	Arm VI (SER [DECA, ABVE-PC, IFRT]) n=153 Participants SER - randomized to DECAX2 + ABVE-PCX2 + IFRT	Arm VII (SER [ABVE-PC, IFRT]) n=152 Participants SER - randomized to ABVE-PCX2 + IFRT
Event-free Survival	0.89 Probability of survival Interval 0.69 to 0.96	0.87 Probability of survival Interval 0.83 to 0.9	0.84 Probability of survival Interval 0.8 to 0.87	0.87 Probability of survival Interval 0.83 to 0.89	0.70 Probability of survival Interval 0.51 to 0.82	0.79 Probability of survival Interval 0.71 to 0.85	0.74 Probability of survival Interval 0.66 to 0.8

SECONDARY outcome

Timeframe: Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.

Population: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

Number of participants with complete response and very good partial response at the end of protocol therapy.

Outcome measures

Outcome measures
Measure	Arm I (Patients Off-therapy Before Callback-Induction Only) n=38 Participants All patients-off therapy before callback-Induction only	Arm II (RER With CR [ABVE-PC, IFRT]) n=380 Participants RER with Complete Response - IFRT (Standard Arm)	Arm III (RER With CR [ABVE-PC]) n=382 Participants RER with Complete Response - no IFRT (Reduced Therapy Arm)	Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) n=571 Participants RER with less than Complete Response - IFRT	Arm V (RER With PD) n=36 Participants RER with Progressive Disease - Off Therapy	Arm VI (SER [DECA, ABVE-PC, IFRT]) n=153 Participants SER - randomized to DECAX2 + ABVE-PCX2 + IFRT	Arm VII (SER [ABVE-PC, IFRT]) n=152 Participants SER - randomized to ABVE-PCX2 + IFRT
Disease Response Assessed by Modified RECIST Criteria	5 Number of participants	370 Number of participants	380 Number of participants	538 Number of participants	29 Number of participants	105 Number of participants	100 Number of participants

SECONDARY outcome

Timeframe: Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.

Population: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.

Outcome measures

Outcome measures
Measure	Arm I (Patients Off-therapy Before Callback-Induction Only) n=38 Participants All patients-off therapy before callback-Induction only	Arm II (RER With CR [ABVE-PC, IFRT]) n=380 Participants RER with Complete Response - IFRT (Standard Arm)	Arm III (RER With CR [ABVE-PC]) n=382 Participants RER with Complete Response - no IFRT (Reduced Therapy Arm)	Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) n=571 Participants RER with less than Complete Response - IFRT	Arm V (RER With PD) n=36 Participants RER with Progressive Disease - Off Therapy	Arm VI (SER [DECA, ABVE-PC, IFRT]) n=153 Participants SER - randomized to DECAX2 + ABVE-PCX2 + IFRT	Arm VII (SER [ABVE-PC, IFRT]) n=152 Participants SER - randomized to ABVE-PCX2 + IFRT
Grade 3 or 4 Non-hematologic Toxicity	10 Number of participants	153 Number of participants	130 Number of participants	216 Number of participants	11 Number of participants	62 Number of participants	45 Number of participants

SECONDARY outcome

Timeframe: 5 years

Population: Arm V (RER with PD), has been excluded as there were no deaths observed by the Time Frame of 5 years. Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact.

Outcome measures

Outcome measures
Measure	Arm I (Patients Off-therapy Before Callback-Induction Only) n=38 Participants All patients-off therapy before callback-Induction only	Arm II (RER With CR [ABVE-PC, IFRT]) n=380 Participants RER with Complete Response - IFRT (Standard Arm)	Arm III (RER With CR [ABVE-PC]) n=382 Participants RER with Complete Response - no IFRT (Reduced Therapy Arm)	Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) n=571 Participants RER with less than Complete Response - IFRT	Arm V (RER With PD) n=153 Participants RER with Progressive Disease - Off Therapy	Arm VI (SER [DECA, ABVE-PC, IFRT]) n=152 Participants SER - randomized to DECAX2 + ABVE-PCX2 + IFRT	Arm VII (SER [ABVE-PC, IFRT]) SER - randomized to ABVE-PCX2 + IFRT
Overall Survival	0.93 Probability of survival Interval 0.74 to 0.98	0.98 Probability of survival Interval 0.96 to 0.99	0.98 Probability of survival Interval 0.96 to 0.99	0.98 Probability of survival Interval 0.96 to 0.99	0.96 Probability of survival Interval 0.91 to 0.98	0.93 Probability of survival Interval 0.87 to 0.96	—

Adverse Events

Arm I (Patients Off-therapy Before Callback-Induction Only)

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Arm II (RER With CR [ABVE-PC, IFRT])

Serious events: 2 serious events

Other events: 341 other events

Deaths: 0 deaths

Arm III (RER With CR [ABVE-PC])

Serious events: 1 serious events

Other events: 334 other events

Deaths: 0 deaths

Arm IV (RER With Less Than CR [ABVE-PC, IFRT])

Serious events: 5 serious events

Other events: 497 other events

Deaths: 0 deaths

Arm V (RER With PD)

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Arm VI (SER [DECA, ABVE-PC, IFRT])

Serious events: 2 serious events

Other events: 135 other events

Deaths: 0 deaths

Arm VII (SER [ABVE-PC, IFRT])

Serious events: 1 serious events

Other events: 133 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Patients Off-therapy Before Callback-Induction Only) n=38 participants at risk Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm II (RER With CR [ABVE-PC, IFRT]) n=380 participants at risk Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm III (RER With CR [ABVE-PC]) n=382 participants at risk Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) n=571 participants at risk Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm V (RER With PD) n=36 participants at risk Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm VI (SER [DECA, ABVE-PC, IFRT]) n=153 participants at risk Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \& G-CSF SC beginning on day 3 \& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cisplatin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Dexamethasone: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Pre	Arm VII (SER [ABVE-PC, IFRT]) n=152 participants at risk Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
Investigations White blood cell decreased	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Platelet count decreased	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Blood and lymphatic system disorders Anemia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Diarrhea	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Nausea	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Vomiting	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Immune system disorders Anaphylaxis	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.8% 1/36 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Blood antidiuretic hormone abnormal	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Lymphocyte count decreased	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Neutrophil count decreased	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Nervous system disorders Peripheral motor neuropathy	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

Other adverse events

Other adverse events
Measure	Arm I (Patients Off-therapy Before Callback-Induction Only) n=38 participants at risk Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm II (RER With CR [ABVE-PC, IFRT]) n=380 participants at risk Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm III (RER With CR [ABVE-PC]) n=382 participants at risk Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) n=571 participants at risk Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm V (RER With PD) n=36 participants at risk Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	Arm VI (SER [DECA, ABVE-PC, IFRT]) n=153 participants at risk Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \& G-CSF SC beginning on day 3 \& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cisplatin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Dexamethasone: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Pre	Arm VII (SER [ABVE-PC, IFRT]) n=152 participants at risk Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
Blood and lymphatic system disorders Anemia	10.5% 4/38 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	51.6% 196/380 • Number of events 196 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	42.4% 162/382 • Number of events 162 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	42.9% 245/571 • Number of events 245 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	33.3% 12/36 • Number of events 12 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	55.6% 85/153 • Number of events 85 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	41.4% 63/152 • Number of events 63 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	13.2% 50/380 • Number of events 50 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	9.2% 35/382 • Number of events 35 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	10.0% 57/571 • Number of events 57 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	20.3% 31/153 • Number of events 31 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	13.2% 20/152 • Number of events 20 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Blood and lymphatic system disorders Disseminated intravascular coagulation	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Blood and lymphatic system disorders Febrile neutropenia	13.2% 5/38 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	29.2% 111/380 • Number of events 111 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	25.9% 99/382 • Number of events 99 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	22.4% 128/571 • Number of events 128 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	8.3% 3/36 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	29.4% 45/153 • Number of events 45 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	20.4% 31/152 • Number of events 31 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Cardiac disorders Cardiac disorders - Other, specify	5.3% 2/38 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.0% 3/153 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Cardiac disorders Left ventricular systolic dysfunction	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Cardiac disorders Sinus tachycardia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Cardiac disorders Supraventricular tachycardia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Ear and labyrinth disorders Hearing impaired	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Endocrine disorders Endocrine disorders - Other, specify	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Eye disorders Blurred vision	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Eye disorders Eye disorders - Other, specify	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Abdominal pain	5.3% 2/38 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.1% 4/380 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.6% 6/382 • Number of events 6 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.1% 12/571 • Number of events 12 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Anal fistula	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Ascites	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Colitis	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.79% 3/380 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.88% 5/571 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Constipation	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.1% 4/380 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.0% 4/382 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.8% 1/36 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Diarrhea	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.6% 9/571 • Number of events 9 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.0% 3/153 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Dyspepsia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Dysphagia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Esophagitis	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Ileus	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.79% 3/380 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 3/571 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Mucositis oral	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	5.3% 20/380 • Number of events 20 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.4% 9/382 • Number of events 9 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	4.4% 25/571 • Number of events 25 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.8% 1/36 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	6.5% 10/153 • Number of events 10 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/152 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Nausea	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.6% 6/380 • Number of events 6 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 5/382 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.7% 21/571 • Number of events 21 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.9% 6/153 • Number of events 6 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/152 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Pancreatitis	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Rectal pain	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Typhlitis	7.9% 3/38 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.1% 4/380 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.79% 3/382 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.2% 7/571 • Number of events 7 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Gastrointestinal disorders Vomiting	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.6% 6/380 • Number of events 6 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.4% 9/382 • Number of events 9 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.3% 19/571 • Number of events 19 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	5.9% 9/153 • Number of events 9 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.0% 3/152 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
General disorders Chills	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
General disorders Fatigue	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 3/571 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
General disorders Fever	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.88% 5/571 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
General disorders Non-cardiac chest pain	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/153 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
General disorders Pain	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.1% 4/380 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.0% 4/382 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.3% 13/571 • Number of events 13 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/153 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Immune system disorders Anaphylaxis	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.7% 14/380 • Number of events 14 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.1% 8/382 • Number of events 8 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.5% 20/571 • Number of events 20 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.8% 1/36 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.6% 4/153 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.9% 6/152 • Number of events 6 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Immune system disorders Immune system disorders - Other, specify	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Infections and infestations Catheter related infection	7.9% 3/38 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.7% 14/380 • Number of events 14 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.4% 13/382 • Number of events 13 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.0% 17/571 • Number of events 17 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.8% 1/36 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.0% 3/153 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.6% 4/152 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Infections and infestations Infections and infestations - Other, specify	10.5% 4/38 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	18.7% 71/380 • Number of events 71 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	16.0% 61/382 • Number of events 61 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	13.8% 79/571 • Number of events 79 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	16.7% 6/36 • Number of events 6 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	17.0% 26/153 • Number of events 26 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	10.5% 16/152 • Number of events 16 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Infections and infestations Wound infection	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/153 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Activated partial thromboplastin time prolonged	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Alanine aminotransferase increased	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.88% 5/571 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/152 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Aspartate aminotransferase increased	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Blood antidiuretic hormone abnormal	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Blood bilirubin increased	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 3/571 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Carbon monoxide diffusing capacity decreased	5.3% 2/38 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.9% 11/380 • Number of events 11 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.79% 3/382 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.9% 11/571 • Number of events 11 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.0% 3/153 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Cardiac troponin I increased	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Fibrinogen decreased	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Forced expiratory volume decreased	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations INR increased	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.79% 3/380 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Investigations - Other, specify	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/153 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Lipase increased	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Lymphocyte count decreased	5.3% 2/38 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.7% 14/380 • Number of events 14 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	5.0% 19/382 • Number of events 19 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	9.3% 53/571 • Number of events 53 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.8% 1/36 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	15.7% 24/153 • Number of events 24 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	11.2% 17/152 • Number of events 17 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Neutrophil count decreased	44.7% 17/38 • Number of events 17 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	83.9% 319/380 • Number of events 319 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	80.4% 307/382 • Number of events 307 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	78.6% 449/571 • Number of events 449 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	55.6% 20/36 • Number of events 20 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	82.4% 126/153 • Number of events 126 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	76.3% 116/152 • Number of events 116 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Platelet count decreased	7.9% 3/38 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	40.0% 152/380 • Number of events 152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	31.2% 119/382 • Number of events 119 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	29.2% 167/571 • Number of events 167 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	13.9% 5/36 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	64.1% 98/153 • Number of events 98 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	36.2% 55/152 • Number of events 55 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Serum amylase increased	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations Weight loss	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Investigations White blood cell decreased	13.2% 5/38 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	18.7% 71/380 • Number of events 71 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	18.1% 69/382 • Number of events 69 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	22.1% 126/571 • Number of events 126 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.8% 1/36 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	32.7% 50/153 • Number of events 50 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	20.4% 31/152 • Number of events 31 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Acidosis	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Anorexia	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.1% 4/380 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.0% 3/153 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Dehydration	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.79% 3/380 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.6% 10/382 • Number of events 10 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.6% 9/571 • Number of events 9 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/153 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/152 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Hyperglycemia	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.8% 7/380 • Number of events 7 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 5/382 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.70% 4/571 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.8% 1/36 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	5.2% 8/153 • Number of events 8 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 3/571 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.0% 3/153 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Hypoalbuminemia	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Hypocalcemia	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.1% 4/380 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 3/571 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Hypokalemia	5.3% 2/38 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.2% 12/380 • Number of events 12 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.8% 7/382 • Number of events 7 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.0% 17/571 • Number of events 17 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	3.3% 5/153 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Hyponatremia	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.8% 7/380 • Number of events 7 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.0% 4/382 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.6% 9/571 • Number of events 9 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/153 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.88% 5/571 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.0% 3/153 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.79% 3/382 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.2% 7/571 • Number of events 7 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.6% 4/152 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.70% 4/571 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Nervous system disorders Dizziness	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Nervous system disorders Headache	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.1% 4/380 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.79% 3/382 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.1% 6/571 • Number of events 6 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Nervous system disorders Neuralgia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.8% 7/380 • Number of events 7 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.79% 3/382 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.1% 6/571 • Number of events 6 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Nervous system disorders Peripheral motor neuropathy	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.79% 3/382 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.4% 8/571 • Number of events 8 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.8% 1/36 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 5/382 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.70% 4/571 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.8% 1/36 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Nervous system disorders Pyramidal tract syndrome	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Nervous system disorders Seizure	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Nervous system disorders Syncope	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 5/380 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 5/382 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.2% 7/571 • Number of events 7 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/153 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Nervous system disorders Vasovagal reaction	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Psychiatric disorders Anxiety	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 3/571 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/152 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Psychiatric disorders Depression	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Psychiatric disorders Insomnia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.35% 2/571 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Psychiatric disorders Personality change	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 3/571 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Psychiatric disorders Psychosis	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/382 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Reproductive system and breast disorders Irregular menstruation	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Respiratory, thoracic and mediastinal disorders Dyspnea	2.6% 1/38 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.79% 3/382 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.88% 5/571 • Number of events 5 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.79% 3/380 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.70% 4/571 • Number of events 4 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.3% 2/38 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 2/380 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.18% 1/571 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/153 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Vascular disorders Hypertension	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.26% 1/380 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.53% 3/571 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.65% 1/153 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.66% 1/152 • Number of events 1 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Vascular disorders Hypotension	5.3% 2/38 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.9% 11/380 • Number of events 11 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.1% 8/382 • Number of events 8 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.3% 13/571 • Number of events 13 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/153 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/152 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Vascular disorders Thromboembolic event	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.8% 7/380 • Number of events 7 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.52% 2/382 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.5% 14/571 • Number of events 14 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.0% 3/153 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	2.0% 3/152 • Number of events 3 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Vascular disorders Vascular disorders - Other, specify	0.00% 0/38 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/380 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/382 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/571 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/36 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	1.3% 2/153 • Number of events 2 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).	0.00% 0/152 Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Must obtain prior approval.
Publication restrictions are in place

Restriction type: OTHER