Trial Outcomes & Findings for AZD1775 for Advanced Solid Tumors (NCT NCT01748825)

Last Updated: 2021-07-26

Results Overview

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

67 participants

Primary outcome timeframe

Date treatment consent signed to date off study, approx.19 mo/8 d for A1, 3 mo/28 d for A2, 10 mo/28 d for A3, 2 mo/14 d for A4, 20 mo/24 d for A5, 10 mo/23 d for A6, 4 mo/23 d for A7, 14 mo/11 d for A8, 15 mo/24 d for A9, and 77 mo/6 d for A10.

Results posted on

2021-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	ARM 1 AZD1775 200 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily	ARM 2 AZD1775 225 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily	ARM 3 AZD1775 225 mg Twice Daily Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily	ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing) Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)	ARM 5 AZD1775 250 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily	ARM 6 AZD1775 300 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) once daily	ARM 7 AZD1775 300 mg Twice Daily Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily	ARM 8 AZD1775 400 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily	ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily	ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
Dose Escalation STARTED	6	4	6	3	3	6	3	3	0	0
Dose Escalation COMPLETED	4	2	6	2	2	4	2	3	0	0
Dose Escalation NOT COMPLETED	2	2	0	1	1	2	1	0	0	0
Dose Expansion STARTED	0	0	0	0	0	0	0	0	13	20
Dose Expansion COMPLETED	0	0	0	0	0	0	0	0	11	15
Dose Expansion NOT COMPLETED	0	0	0	0	0	0	0	0	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	ARM 1 AZD1775 200 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily	ARM 2 AZD1775 225 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily	ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing) Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)	ARM 5 AZD1775 250 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily	ARM 6 AZD1775 300 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) once daily	ARM 7 AZD1775 300 mg Twice Daily Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily	ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily	ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
Dose Escalation Refused further treatment	2	2	0	1	2	0	0	0
Dose Escalation Switched to alternative treatment	0	0	1	0	0	0	0	0
Dose Escalation Adverse Event	0	0	0	0	0	1	0	0
Dose Expansion Refused further treatment	0	0	0	0	0	0	1	1
Dose Expansion Switched to alternative treatment	0	0	0	0	0	0	0	1
Dose Expansion Adverse Event	0	0	0	0	0	0	0	3
Dose Expansion Physician Decision	0	0	0	0	0	0	1	0

Baseline Characteristics

AZD1775 for Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARM 1 AZD1775 200 mg Once Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily	ARM 2 AZD1775 225 mg Once Daily n=4 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily	ARM 3 AZD1775 225 mg Twice Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily	ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing) n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)	ARM 5 AZD1775 250 mg Once Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily	ARM 6 AZD1775 300 mg Once Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) once daily	ARM 7 AZD1775 300 mg Twice Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily	ARM 8 AZD1775 400 mg Once Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily	ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily n=13 Participants Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily	ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily n=20 Participants Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 Participants	12 Participants n=42 Participants	8 Participants n=42 Participants	44 Participants n=42 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	12 Participants n=42 Participants	23 Participants n=42 Participants
Age, Continuous	58.17 years STANDARD_DEVIATION 19 • n=5 Participants	58.13 years STANDARD_DEVIATION 21.56 • n=7 Participants	46.18 years STANDARD_DEVIATION 19.26 • n=5 Participants	48.4 years STANDARD_DEVIATION 20.88 • n=4 Participants	58.33 years STANDARD_DEVIATION 4.1 • n=21 Participants	56.97 years STANDARD_DEVIATION 15.39 • n=8 Participants	65.07 years STANDARD_DEVIATION 10.51 • n=8 Participants	63.13 years STANDARD_DEVIATION 14.74 • n=24 Participants	51.49 years STANDARD_DEVIATION 10.82 • n=42 Participants	65.59 years STANDARD_DEVIATION 8.57 • n=42 Participants	58 years STANDARD_DEVIATION 14.38 • n=42 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	12 Participants n=42 Participants	16 Participants n=42 Participants	44 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	23 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	12 Participants n=42 Participants	19 Participants n=42 Participants	64 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	7 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	12 Participants n=42 Participants	15 Participants n=42 Participants	54 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Region of Enrollment United States	6 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants	3 participants n=4 Participants	3 participants n=21 Participants	6 participants n=8 Participants	3 participants n=8 Participants	3 participants n=24 Participants	13 participants n=42 Participants	20 participants n=42 Participants	67 participants n=42 Participants
Tumor Type Ovarian carcinoma	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	1 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	4 Participants n=42 Participants	6 Participants n=42 Participants	14 Participants n=42 Participants
Tumor Type Endometrial carcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants
Tumor Type Mesothelioma	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants
Tumor Type Breast carcinoma	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	2 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	8 Participants n=42 Participants
Tumor Type Alveolar soft part sarcoma	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Tumor Type Colon adenocarcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants
Tumor Type Leiomyosarcoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants
Tumor Type Pancreatic carcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants
Tumor Type Prostate carcinoma	1 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Tumor Type Bladder carcinoma	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Cervical carcinoma	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Tumor Type Cholangiocarcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Endometrial carcinosarcoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Tumor Type Liposarcoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants
Tumor Type Pleomorphic sarcoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Synovial cell sarcoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Uterine carcinosarcoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants
Tumor Type Non-small cell lung cancer	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants
Tumor Type Papillary serous ovarian carcinoma	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Tumor Type Squamous cell carcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Tumor Type Synovial cell carcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Hepatocellular carcinoma	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Malignant fibrous histiocytoma sarcoma	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Salivary adenocarcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Ewing sarcoma	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Fallopian tube carcinoma	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Sinonasal leiomyosarcoma	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Atypical granular cell paraspinal	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Peritoneal carcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Tumor Type Embryonal cell	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Tumor Type Appendiceal carcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Eastern Cooperative Oncology Score (ECOG) 0	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	7 Participants n=42 Participants
Eastern Cooperative Oncology Score (ECOG) 1	5 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	13 Participants n=42 Participants	17 Participants n=42 Participants	60 Participants n=42 Participants
Median Number of Prior Therapies	5 prior therapy n=5 Participants	3.5 prior therapy n=7 Participants	7.5 prior therapy n=5 Participants	11 prior therapy n=4 Participants	4 prior therapy n=21 Participants	3 prior therapy n=8 Participants	2 prior therapy n=8 Participants	15 prior therapy n=24 Participants	7 prior therapy n=42 Participants	8 prior therapy n=42 Participants	7 prior therapy n=42 Participants

PRIMARY outcome

Timeframe: Date treatment consent signed to date off study, approx.19 mo/8 d for A1, 3 mo/28 d for A2, 10 mo/28 d for A3, 2 mo/14 d for A4, 20 mo/24 d for A5, 10 mo/23 d for A6, 4 mo/23 d for A7, 14 mo/11 d for A8, 15 mo/24 d for A9, and 77 mo/6 d for A10.

Outcome measures

Outcome measures
Measure	ARM 1 AZD1775 200 mg Once Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily	ARM 2 AZD1775 225 mg Once Daily n=4 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily	ARM 3 AZD1775 225 mg Twice Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily	ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing) n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)	ARM 5 AZD1775 250 mg Once Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily	ARM 6 AZD1775 300 mg Once Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) once daily	ARM 7 AZD1775 300 mg Twice Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily	ARM 8 AZD1775 400 mg Once Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily	ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily n=13 Participants Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily	ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily n=20 Participants Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
To Establish the Safety and Tolerability of Single-agent AZD1775 in Patients With Refractory Solid Tumors	6 Participants	4 Participants	6 Participants	3 Participants	3 Participants	6 Participants	3 Participants	3 Participants	13 Participants	20 Participants

PRIMARY outcome

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe or medically significant but not immediately life-threatening. Grade 4 is life-threatening.

Outcome measures

Outcome measures
Measure	ARM 1 AZD1775 200 mg Once Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily	ARM 2 AZD1775 225 mg Once Daily n=4 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily	ARM 3 AZD1775 225 mg Twice Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily	ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing) n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)	ARM 5 AZD1775 250 mg Once Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily	ARM 6 AZD1775 300 mg Once Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) once daily	ARM 7 AZD1775 300 mg Twice Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily	ARM 8 AZD1775 400 mg Once Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily	ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily n=13 Participants Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily	ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily n=20 Participants Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
Establish the Safety and Tolerability of Single-agent AZD1775 in Patients With Refractory Solid Tumors Grade 1-2 Anemia	50 percentage of participants	75 percentage of participants	50 percentage of participants	67 percentage of participants	33 percentage of participants	67 percentage of participants	67 percentage of participants	100 percentage of participants	69 percentage of participants	60 percentage of participants
Establish the Safety and Tolerability of Single-agent AZD1775 in Patients With Refractory Solid Tumors Grade 3 Anemia	33 percentage of participants	25 percentage of participants	17 percentage of participants	67 percentage of participants	0 percentage of participants	33 percentage of participants	33 percentage of participants	67 percentage of participants	15 percentage of participants	30 percentage of participants
Establish the Safety and Tolerability of Single-agent AZD1775 in Patients With Refractory Solid Tumors Grade 1-2 Lymphopenia	50 percentage of participants	75 percentage of participants	67 percentage of participants	67 percentage of participants	33 percentage of participants	67 percentage of participants	67 percentage of participants	67 percentage of participants	54 percentage of participants	80 percentage of participants
Establish the Safety and Tolerability of Single-agent AZD1775 in Patients With Refractory Solid Tumors Grade 3 Lymphopenia	50 percentage of participants	25 percentage of participants	17 percentage of participants	33 percentage of participants	33 percentage of participants	17 percentage of participants	33 percentage of participants	67 percentage of participants	8 percentage of participants	25 percentage of participants
Establish the Safety and Tolerability of Single-agent AZD1775 in Patients With Refractory Solid Tumors Grade 4 Lymphopenia	0 percentage of participants	0 percentage of participants	0 percentage of participants	33 percentage of participants	0 percentage of participants	0 percentage of participants	33 percentage of participants	0 percentage of participants	0 percentage of participants	10 percentage of participants
Establish the Safety and Tolerability of Single-agent AZD1775 in Patients With Refractory Solid Tumors Grade 1-2 Neutropenia	17 percentage of participants	25 percentage of participants	17 percentage of participants	0 percentage of participants	33 percentage of participants	17 percentage of participants	33 percentage of participants	100 percentage of participants	23 percentage of participants	25 percentage of participants
Establish the Safety and Tolerability of Single-agent AZD1775 in Patients With Refractory Solid Tumors Grade 3 Neutropenia	17 percentage of participants	25 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	33 percentage of participants	67 percentage of participants	8 percentage of participants	30 percentage of participants
Establish the Safety and Tolerability of Single-agent AZD1775 in Patients With Refractory Solid Tumors Grade 4 Neutropenia	17 percentage of participants	0 percentage of participants	0 percentage of participants	33 percentage of participants	0 percentage of participants	0 percentage of participants	33 percentage of participants	33 percentage of participants	0 percentage of participants	20 percentage of participants

PRIMARY outcome

Timeframe: Pre-Treatment (Baseline) and Cycle 1 Days 1 and 3 (Arms 3 and 7) or Days 1 and 5 (Arms 1-2, 5-6, and 8)

Population: Participants are grouped by dose level. Arm 3 represents combined data for patients receiving 225 mg twice daily on days 1-2 and once on day 3 of each 21-day cycle and for patients receiving 225 mg twice daily on days 1-2 and 8-9 and once on days 3 and 10 (the latter includes both dose escalation and expansion phase patients); these data are combined because all of these patients received the same dose over the pharmacokinetic analysis period (cycle 1 days 1-3).

Mean plasma concentration (± standard deviation) of AZD1775 at baseline and after AZD1775 administration.

Outcome measures

Outcome measures
Measure	ARM 1 AZD1775 200 mg Once Daily n=4 Participants Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily	ARM 2 AZD1775 225 mg Once Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily	ARM 3 AZD1775 225 mg Twice Daily n=15 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily	ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing) n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)	ARM 5 AZD1775 250 mg Once Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily	ARM 6 AZD1775 300 mg Once Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) once daily	ARM 7 AZD1775 300 mg Twice Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily	ARM 8 AZD1775 400 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily	ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily	ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 3, 1 hour post-dose	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	983 nM Standard Error 522	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	2090 nM Standard Error 403	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Pre-Treatment (Baseline)	0 nM Standard Error 0	0 nM Standard Error 0	0 nM Standard Error 0	0 nM Standard Error 0	0 nM Standard Error 0	0 nM Standard Error 0	0 nM Standard Error 0	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 1, 1 hour post-dose	135 nM Standard Error 230	577 nM Standard Error 248	262 nM Standard Error 257	539 nM Standard Error 236	426 nM Standard Error 377	452 nM Standard Error 402	641 nM Standard Error 452	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 1, 2 hours post-dose	402 nM Standard Error 327	1017 nM Standard Error 442	592 nM Standard Error 354	766 nM Standard Error 36	997 nM Standard Error 703	878 nM Standard Error 263	1407 nM Standard Error 314	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 1, 4 hours post-dose	600 nM Standard Error 18	876 nM Standard Error 420	661 nM Standard Error 212	636 nM Standard Error 43	979 nM Standard Error 491	975 nM Standard Error 361	1757 nM Standard Error 351	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 1, 6 hours post-dose	579 nM Standard Error 152	677 nM Standard Error 351	556 nM Standard Error 210	462 nM Standard Error 23	744 nM Standard Error 412	780 nM Standard Error 222	1537 nM Standard Error 469	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 1, 8 hours post-dose	416 nM Standard Error 153	521 nM Standard Error 232	422 nM Standard Error 180	276 nM Standard Error 101	604 nM Standard Error 373	586 nM Standard Error 209	1063 nM Standard Error 256	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 3, pre-dose	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	776 nM Standard Error 341	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	1560 nM Standard Error 414	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 3, 2 hours post-dose	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	1350 nM Standard Error 673	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	2440 nM Standard Error 571	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 3, 4 hours post-dose	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	1440 nM Standard Error 655	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	2450 nM Standard Error 583	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 3, 6 hours post-dose	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	1210 nM Standard Error 633	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	2190 nM Standard Error 437	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 3, 8 hours post-dose	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	1030 nM Standard Error 509	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	1980 nM Standard Error 455	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 5, pre-dose	235 nM Standard Error 55	325 nM Standard Error 231	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	167 nM Standard Error 48	237 nM Standard Error 82	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	671 nM Standard Error 156	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 5, 1 hour post-dose	461 nM Standard Error 108	961 nM Standard Error 492	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	734 nM Standard Error 88	774 nM Standard Error 394	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	1970 nM Standard Error 301	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 5, 2 hours post-dose	782 nM Standard Error 83	1128 nM Standard Error 465	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	1135 nM Standard Error 266	1697 nM Standard Error 1062	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	3036 nM Standard Error 572	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 5, 4 hours post-dose	952 nM Standard Error 66	1115 nM Standard Error 440	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	1114 nM Standard Error 238	1638 nM Standard Error 860	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	2597 nM Standard Error 211	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 5, 6 hours post-dose	790 nM Standard Error 95	985 nM Standard Error 441	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	787 nM Standard Error 177	1222 nM Standard Error 491	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	2062 nM Standard Error 511	—	—	—
To Determine the Pharmacokinetics of AZD1775 in Patients With Refractory Solid Tumors. Cycle 1 Day 5, 8 hours post-dose	597 nM Standard Error 79	892 nM Standard Error 367	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	605 nM Standard Error 147	965 nM Standard Error 388	NA nM Standard Error NA not applicable per protocol, as the protocol specified pharmacokinetic sample collection on days 1 and 3 for patients receiving twice-daily AZD1775 and on days 1 and 5 for patients receiving once-daily AZD1775.	1697 nM Standard Error 115	—	—	—

SECONDARY outcome

Timeframe: 21 days

Objective Response is defined as a Complete Response + Partial Response and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	ARM 1 AZD1775 200 mg Once Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily	ARM 2 AZD1775 225 mg Once Daily n=4 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily	ARM 3 AZD1775 225 mg Twice Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily	ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing) n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)	ARM 5 AZD1775 250 mg Once Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily	ARM 6 AZD1775 300 mg Once Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) once daily	ARM 7 AZD1775 300 mg Twice Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily	ARM 8 AZD1775 400 mg Once Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily	ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily n=13 Participants Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily	ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily n=20 Participants Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
To Evaluate the Antitumor Activity of AZD1775 in Patients With Refractory Solid Tumors Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
To Evaluate the Antitumor Activity of AZD1775 in Patients With Refractory Solid Tumors Partial Response	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: First cycle (21 days) of treatment

DLT is defined as an adverse event that is related (possibly, probably, or definitely) to administration of MK-1775 (Adavosertib (AZD1775). Examples are Grade ≥ 3 non-hematological toxicity, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia associated with bleeding, Grade 3 fatigue of greater than 1 week duration, and failure to tolerate 100% of the dosing in the first cycle will be considered a DLT, etc.

Outcome measures

Outcome measures
Measure	ARM 1 AZD1775 200 mg Once Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily	ARM 2 AZD1775 225 mg Once Daily n=4 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily	ARM 3 AZD1775 225 mg Twice Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily	ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing) n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)	ARM 5 AZD1775 250 mg Once Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily	ARM 6 AZD1775 300 mg Once Daily n=6 Participants Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) once daily	ARM 7 AZD1775 300 mg Twice Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily	ARM 8 AZD1775 400 mg Once Daily n=3 Participants Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily	ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily	ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
Number of Participants With a Dose-Limiting Toxicity (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	—	—

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	ARM 1 AZD1775 200 mg Once Daily n=6 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily	ARM 2 AZD1775 225 mg Once Daily n=4 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily	ARM 3 AZD1775 225 mg Twice Daily n=6 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily	ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing) n=3 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)	ARM 5 AZD1775 250 mg Once Daily n=3 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily	ARM 6 AZD1775 300 mg Once Daily n=6 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily	ARM 7 AZD1775 300 mg Twice Daily n=3 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily	ARM 8 AZD1775 400 mg Once Daily n=3 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily	ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily n=13 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily	ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily n=20 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
Investigations Neutrophil count decreased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Injury, poisoning and procedural complications Acute kidney injury	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Blood and lymphatic system disorders Anemia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Anorexia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Ascites	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Bronchial infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Bronchial stricture	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Colonic fistula	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Psychiatric disorders Confusion	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Constipation	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Creatinine increased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Death NOS	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Diarrhea	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Disease progression	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Ejection fraction decreased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Fatigue	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Fever	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Injury, poisoning and procedural complications Fracture	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Gastrointestinal disorders - Other, Gastrointestinal DIS;Hernia Wrapped around bowel	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Headache	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Renal and urinary disorders Hematuria	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Vascular disorders Hypertension	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	20.0% 4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypophosphatemia	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Vascular disorders Hypotension	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Lung infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Lymphocyte count decreased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Pancreatitis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Paresthesia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Periorbital infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Platelet count decreased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Rectal obstruction	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Respiratory - Pneumonia	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Sepsis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Cardiac disorders Sinus tachycardia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Stroke	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Cardiac disorders Supraventricular tachycardia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Surgical and medical procedures Surgical and medical procedures - Other, Surgical and medical procedures - Pleurodesis, pleurx	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Surgical and medical procedures Surgical and medical procedures - Other, Surgical and medical procedures - Thoracentesis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Vascular disorders Thromboembolic event	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Upper respiratory infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Urinary tract infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations White blood cell decreased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.

Other adverse events

Other adverse events
Measure	ARM 1 AZD1775 200 mg Once Daily n=6 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 200 mg by mouth (PO) once daily	ARM 2 AZD1775 225 mg Once Daily n=4 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) once daily	ARM 3 AZD1775 225 mg Twice Daily n=6 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily	ARM 4 AZD1775 225 mg Twice Daily (Week 1-only Dosing) n=3 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing)	ARM 5 AZD1775 250 mg Once Daily n=3 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily	ARM 6 AZD1775 300 mg Once Daily n=6 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily	ARM 7 AZD1775 300 mg Twice Daily n=3 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 300 mg by mouth (PO) twice daily	ARM 8 AZD1775 400 mg Once Daily n=3 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 400 mg by mouth (PO) once daily	ARM 9 Expansion Cohort 1: AZD1775 225 mg Twice Daily n=13 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 225mg by mouth (PO) twice daily	ARM 10 Expansion Cohort 2: AZD1775 300 mg Once Daily n=20 participants at risk Cycle = 21 days. MK-1775 (AZD1775) 300mg by mouth (PO) once daily
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 5/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	38.5% 5/13 • Number of events 9 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	20.0% 4/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Activated partial thromboplastin time prolonged	50.0% 3/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 4/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Akathisia	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Alanine aminotransferase increased	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 4/6 • Number of events 7 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	30.8% 4/13 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.0% 3/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Alkaline phosphatase increased	66.7% 4/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	75.0% 3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	30.8% 4/13 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	40.0% 8/20 • Number of events 13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Immune system disorders Allergic reaction	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Anal fissure	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Blood and lymphatic system disorders Anemia	66.7% 4/6 • Number of events 7 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	75.0% 3/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 7 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 4/6 • Number of events 14 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 24 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	69.2% 9/13 • Number of events 23 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	85.0% 17/20 • Number of events 47 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Anorexia	66.7% 4/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	46.2% 6/13 • Number of events 14 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	55.0% 11/20 • Number of events 16 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Psychiatric disorders Anxiety	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 4/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	23.1% 3/13 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	35.0% 7/20 • Number of events 9 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Bloating	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	23.1% 3/13 • Number of events 8 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Blood bilirubin increased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	20.0% 4/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Blood lactate dehydrogenase increased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Eye disorders Blurred vision	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Reproductive system and breast disorders Breast pain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Bronchial infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Injury, poisoning and procedural complications Bruising	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Cardiac troponin I increased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Chills	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.4% 2/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Cholesterol high	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Cognitive disturbance	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Psychiatric disorders Confusion	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Constipation	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	23.1% 3/13 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	35.0% 7/20 • Number of events 13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	20.0% 4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Creatinine increased	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.4% 2/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	20.0% 4/20 • Number of events 8 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	75.0% 3/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Dental caries	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Diarrhea	66.7% 4/6 • Number of events 13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 2/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 4/6 • Number of events 21 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 11 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 4/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 7 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	92.3% 12/13 • Number of events 47 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	70.0% 14/20 • Number of events 24 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Dizziness	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	30.0% 6/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Eye disorders Dry eye	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Dysgeusia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	23.1% 3/13 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Dysphasia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Renal and urinary disorders Dysuria	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Ear and labyrinth disorders Ear pain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Edema face	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Edema limbs	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Cardiac disorders Electrocardiogram QT corrected interval prolonged	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	23.1% 3/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Eye disorders Eye pain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Fatigue	66.7% 4/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.4% 2/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	65.0% 13/20 • Number of events 19 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Fever	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.4% 2/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Eye disorders Flashing lights	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Flatulence	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	23.1% 3/13 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Eye disorders Floaters	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Flu like symptoms	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	30.8% 4/13 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Vascular disorders Flushing	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations GGT increased	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 4/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Gait disturbance	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Gastritis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Gum infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Headache	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 11 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	23.1% 3/13 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Ear and labyrinth disorders Hearing impaired	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Renal and urinary disorders Hematuria	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Renal and urinary disorders Hemoglobinuria	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Hepatobiliary disorders Hepatobiliary disorders - Other, Hepatobiliary disorders - fatty liver	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Vascular disorders Hot flashes	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypercalcemia	50.0% 3/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.4% 2/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	45.0% 9/20 • Number of events 21 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hyperkalemia	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hyperphosphatemia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Vascular disorders Hypertension	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 6/6 • Number of events 13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 7 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	38.5% 5/13 • Number of events 14 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	60.0% 12/20 • Number of events 36 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hyperuricemia	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 3/6 • Number of events 14 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 4/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 4/6 • Number of events 9 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 11 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	69.2% 9/13 • Number of events 14 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	75.0% 15/20 • Number of events 32 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 8 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 9 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	30.8% 4/13 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	20.0% 4/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypomagnesemia	33.3% 2/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 8 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	30.8% 4/13 • Number of events 8 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 5/20 • Number of events 12 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hyponatremia	33.3% 2/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 2/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 7 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.4% 2/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	40.0% 8/20 • Number of events 13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Metabolism and nutrition disorders Hypophosphatemia	66.7% 4/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	30.8% 4/13 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	30.0% 6/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Vascular disorders Hypotension	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	20.0% 4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Infections and infestations - Other, Infections and infestations - MRSA at hospital	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Psychiatric disorders Insomnia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.4% 2/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Investigations - Other, Gamma Glutamyl Transferase increased )GGT)	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Investigations - Other, Protein total decreased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Irritability	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Lip infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Lipase increased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Lung infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Lymphocyte count decreased	83.3% 5/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	75.0% 3/4 • Number of events 12 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 4/6 • Number of events 9 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 10 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 4/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 28 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	53.8% 7/13 • Number of events 11 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	90.0% 18/20 • Number of events 47 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Lymphocyte count increased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Malaise	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Memory impairment	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Mucositis oral	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Cramping of feet	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Nail infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Skin and subcutaneous tissue disorders Nail loss	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Nausea	100.0% 6/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 4/4 • Number of events 8 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 4/6 • Number of events 17 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 11 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	84.6% 11/13 • Number of events 49 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	80.0% 16/20 • Number of events 26 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.4% 2/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Metastatic brain Lesion	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Nervous system disorders - Other, Burnt Smell/Smell sensitivity	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Nervous system disorders - Other, Nervous system disorder - "hangover"	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Nervous system disorders - Other, Nervous system disorders - "foggy and dazed"	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Neutrophil count decreased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 7 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 17 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	30.8% 4/13 • Number of events 11 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	35.0% 7/20 • Number of events 20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Oral pain	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Ear and labyrinth disorders Otitis externa	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
General disorders Pain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Cardiac disorders Palpitations	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Paresthesia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Eye disorders Periorbital edema	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Periorbital infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Pharyngitis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Platelet count decreased	33.3% 2/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 23 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	46.2% 6/13 • Number of events 20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 10/20 • Number of events 31 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Renal and urinary disorders Proteinuria	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Renal and urinary disorders Renal and urinary disorders - Other, Renal and urinary disorders - prostatitis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Serum amylase increased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Cardiac disorders Sinus bradycardia	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Cardiac disorders Sinus tachycardia	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	20.0% 4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Sinusitis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Cellulitis (R leg)	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Somnolence	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Stomach pain	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Stroke	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Surgical and medical procedures Surgical and medical procedures - Other, Surgical and medical procedure - tooth extraction	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Ear and labyrinth disorders Tinnitus	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Nervous system disorders Tremor	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Upper respiratory infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Renal and urinary disorders Urinary frequency	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Renal and urinary disorders Urinary incontinence	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 5/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Renal and urinary disorders Urinary retention	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Infections and infestations Urinary tract infection	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.4% 2/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Renal and urinary disorders Urinary tract pain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	15.4% 2/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Renal and urinary disorders Urine discoloration	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Urine output decreased	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Vascular disorders Vascular disorders - Other, Atherosclerosis	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Gastrointestinal disorders Vomiting	66.7% 4/6 • Number of events 13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	75.0% 3/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	83.3% 5/6 • Number of events 11 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	69.2% 9/13 • Number of events 31 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	75.0% 15/20 • Number of events 25 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Eye disorders Watering eyes	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Weight gain	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/20 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations Weight loss	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	23.1% 3/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	10.0% 2/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	0.00% 0/13 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.
Investigations White blood cell decreased	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	50.0% 3/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 1/3 • Number of events 7 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	100.0% 3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	66.7% 2/3 • Number of events 23 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	53.8% 7/13 • Number of events 14 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.	70.0% 14/20 • Number of events 37 • Date treatment consent signed to date off study, approximately 19 mo. & 8 days for Arm 1, 3 mo. & 28 days for Arm 2, 10 mo. & 28 days for Arm 3, 2 mo. & 14 days for Arm 4, 20 mo. & 24 days for Arm 5, 10 mo. & 23 days for Arm 6, 4 mo. & 23 days for Arm 7, 14 mo. & 11 days for Arm 8, 15 mo. & 24 days for Arm 9, and 77 mo. & 6 days for Arm 10.

Additional Information

Dr. Naoko Takebe

National Cancer Institute

Phone: 240-781-3320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place